What Intuitive Surgical has been desperately maneuvering to prevent you from seeing.

ORIGINAL ARTICLE WITH ALL LINKS HERE: Citron Research report

Citron Research Updates Taylor v Intuitive

March 26, 2013

Intuitive Surgical's Bad Day in Court:  Trial Proceeds in Three Weeks

Citron breaks the latest news on Intuitive Surgical (NASDAQ:ISRG), and presents the documents the
company has been desperately maneuvering to prevent you from seeing.  Intuitive
Surgical motion for summary judgment has been denied, and the documents in the case are now available.  They make for very grim reading. 

Latest Update:  Tuesday March 26:   The judge in Taylor vs Intuitive
Surgical ruled against Intuitive's motions to dismiss in summary judgment.   The case is now set for trial
to begin April 15 th .  The ruling held that negligence and defective product claims will be tried under
Washington's Product Liability Act, while punitive damage claims can be tried under California law.  The
actions will be bifurcated to separate trials, without objection from either side.  ( Click for the ruling ) 

What this is about:
Taylor vs Intuitive is the first of a series of recent liability cases against the company to come to trial.  It
sets a roadmap for all death and serious injury cases against Intuitive, by exposing for the first time, the
company's failure in its commitments to the FDA and to the public, to properly train surgeons to use the
da Vinci robotic surgery suite safely.   

From today's New York Times (here) to last week Bloomberg story (here), Taylor vs Intuitive has begun to focus major press coverage on the real issues of robotic urgery since Citron alerted the Street to it just last month.   Today's Boston Globe (here),  focuses on the Masschusetts Board of Registration in Medicine's advisory letter (here) which cautions about inadequate credentialing of robotic surgeons.

The real questions being raised in Taylor vs Intuitive are not about the da Vinci device in the hands of an extremely skilled robotic surgeon.  What is being exposed is the company's negligence in grossly
undertraining doctors, directly leading to catastrophic outcomes for patients.  As the documents linked
in this piece make starkly clear, the company has been aggressively advising hospitals to lower
training standards for robotic surgery certification, while dumbing down its own training ,
all to get more surgeons doing live cases with the da Vinci sooner and cheaper, at lower cost to the
hospitals, regardless of the risks to the patients. 

Case Background:
Fred Taylor was hospitalized for routine prostate surgery.  Although his obese body build made him a
poor candidate for robotic surgery, he was operated on using the da Vinci robotic device.  Testimony
states that Intuitive Surgical's Clinical Sales Representative (CSR), a company sales position compensated on the number of cases actually done using the system, apparently climbed under the operating table to try to adjust it to hold Mr. Taylor better.  The surgery went very wrong and dragged on for many hours.
At the end, Mr. Taylor was immediately transferred to ICU at another hospital with severe
complications.  Among other bad outcomes, his bowel had been punctured during surgery.  A variety of Citron severe complications ensued; Mr. Taylor died four years later, never having recovered his health from the adverse events of his surgery.  The surgeon performing the surgery had previously performed only one other robotic surgery, and subsequently decided not to perform further robotic surgeries; he felt misled by the company's estimate of training required to obtain proficiency using the da Vinci.

During discovery, counsel for Mr. Taylor's estate obtained numerous pieces of documentary evidence
outlining Intuitive Surgical's culpability in establishing insufficient training for surgeons on the da Vinci. 

The cases tests whether the company is liable for Fred Taylor's injuries and/or subsequent death.  

The Documents Intuitive doesn't want you to see:   

1)   Testimony of Gene Nagel:  Vice President of Training and Development  
Mr. Nagel was in charge of training customers – which included surgeons, and also Intuitive sales staff. 
Education:   Degree in operations management and marketing 
Scientific or medical training: None
First employment:  Salesman in Wine Industry
Next employment:  Sales of medical technology (appx 9 years) 

The Introductory Test for Intuitive was a 10-question multiple choice test given after a 45 minute video. 
The surgeon could not fail – if any wrong answers were selected, the surgeon was just guided
onscreen to try again.  It was impossible to get any questions wrong.   The company sent a certificate of
completion when the quiz was finished.  Nagel testified that he was unaware if anyone had ever failed it.  
Mr. Nagel also testified he was responsible for reducing Phase II (hands on) training at Intuitive's site
from three days to one day. 

Most shockingly, Intuitive's Training department reported to its Sales Department with :
  No medical or scientific oversight
  No minimum skills proficiency 
  No demonstration of knowledge or competency required

2)   Sales Brochure for 2008 "Drive the Curves" 
Internal sales department communication, emphasizing maximizing the number of cases "driven" onto
the da Vinci platform.   Not one word about doctor competency or patient care. 

3)  Dave Carson (area Sales Manager) memo : Sales goals  = number of procedure targets 
Urgent emphasis on meeting sales targets – more cases, no delays, shorter operating suite turnover. 
Not one word about patient outcomes.  

4)  Gilliam (CSM) email re importance of influencing hospital credentialing guidelines.
Reinforcement of the importance of being clinical consultants to client hospitals "especially with
regard to "credentialing guidelines" – essentially influencing hospitals to lower their training
requirements before allowing surgeons to begin to use the da Vinci on actual patients. 

5)  Michael Rose (Clinical Sales Representative for Montana Hospital) email 
Specifically counseling a hospital client to reduce the number of proctored (supervised) surgeries using
Da Vinci from 5 down to 3, and in another category from 3 to 2.  In another email on the same topic, pointing out that the cost to the hospital will be significantly reduced  if this training component is
reduced. 

6)   Internal sales strategy document 
Admits the key sales strategy is to "Create a competitive landscape between hospitals & surgeons". 
(Citron wonders how client hospitals will feel about inking new systems purchase commitments now
that the sales strategy is fully disclosed.)   This strategy includes deeming certain hospitals "Centers of
Excellence" again with no specific training requirements.  It is purely a marketing credential.   
"Drive account procedure growth, leading to capacity and scheduling constraints". 

7)  Intuitive's training brochure for surgeons – four parts – basically two days prior to first da Vinci
procedure on a patient

8)  Email from e-Marketing department re referrals:  Clarifying policies for surgeons to be listed
on Intuitive's patient referral website after 20 surgeries of any complexity. 

9)  Market Protection Email:  CSM to sales department internal  email about granting a client
hospital "market protection".  What right does Intutiive Surgical have to extend such a right to
a hospital?  Was Fred Taylor's surgery, or dozens of others hurriedly scheduled under pressure
from Intuitive to gain or keep "market protection" ?

10)  Email from VP of sales about pounding the bushes for cases, going the extra mile, and "scrub
all schedules" and "turn over every stone possible" to find one or two more cases to meet
sales targets.  How is this the practice of medicine?  

11) Taylor Post-operative notes – stool coming out urinary catheter 



Conclusion  
Taylor v Intuitive will have tremendous impact on Intuitive Surgical's sales pipeline.  Clearly Intuitive
Surgical lost its moral and ethical compass somewhere a few years ago, and set forth on a "sales at all
costs" strategy. This has led it to a variety of actions for which it will now be held accountable, including: 
  Manipulating  hospitals buying committees with promises of "exclusivity"
  Deeming certain hospitals "Centers of Excellence" designation for marketing benefit without
establishing any professional criteria 
  Producing a training program wholly inadequate to fully and properly train a surgeon to prevent
serious injury or death to the early patients exposed to the surgeon after such training 
  Flogging sales team members to pressure hospitals to convert as many procedures as possible
to use the robotic surgery suite, regardless of the clinical appropriateness of the cases in
question

Compensating Sales team members directly for numbers of procedures done, without disclosing
this to the client hospitals, where these personnel are often right in the surgical suite – during
surgeries.  But worst of all, pressuring hospitals to reduce credentialing standards for surgeons, while dumbing down its own training – all the while with the training department reporting to nobody
except sales. 

Again, Citron is not stating that in the context of an appropriate case, a da Vinci in the hands of a highly
trained and experienced surgeon might deliver a great outcome.  But it is clear that the solution has
been heavily over-marketed, with training and its concomitant costs grossly short-changed, with huge costs in terms of adverse outcomes and deaths to patients.  Further, these adverse outcomes have been chronically underreported.   After hundreds of thousands of surgeries, the company has no data to support the correlation between adverse outcomes and surgeon experience, and no idea how many adverse outcomes of surgery with its product are out there.

Meanwhile, can you find the MAUDE record for Fred Taylor's disastrous surgery?  It doesn’t exist.  So
what are the true number of deaths and serious injuries resulting from inadequate training on da Vinci? 
Answer:  After over 10 years in the field, nobody knows.  Who is going to be held responsible for that? 

It is Citron's opinion that the company is headed for a long period of painful reevaluation of its training
and quality assurance policies, perhaps mandated by more intense FDA scrutiny.  Its relationships with
its client hospitals is going to be much more obstacle laden in future quarters, its reputation will suffer,
and its sales growth will slow.   Hospitals will be re-evaluating their aggressive marketing campaigns for robotic surgery, especially those without proper disclosures of risks.

As it takes its place among its peers in the medical device and technology industry, Intuitive's multiple
will compress to comparable levels, and its share price will fall to appx. half its current levels. 

This is not a "one day wonder" commentary piece.  These consequences are inevitable.  It is shameful
that the company has been so quick to announce a stock buyback, but so reluctant to place its training
operation in the hands of competent arms-length scientific and medical experts accountable to an
independent oversight board.

Intuitive Surgical drops after identifying defect in robot tool

Share of Intuitive Surgical (ISRG), which makes surgical robots, is falling after CNBC reported that the company warned hospitals that a tool on its robots can cause internal burns in patients. WHAT'S NEW: Cracks in some of the scissors used by Intuitive's robots can enable "electrosurgical energy" to leak to patients' tissue and "cause thermal injury," Intuitive stated in a note to hospitals, according to CNBC. The company confirmed that it had sent the notification, but added that it had seen "no evidence of patient injury" caused by the defect, CNBC added. WHAT'S NOTABLE: On March 14, the president of The American Congress of Obstetricians and Gynecologists, Dr. James Breeden, stated that, "Robotic surgery is not the only or the best minimally invasive approach for hysterectomy." The following day, the state of Massachusetts reported that it had been receiving more complaints about patient complications associated with robot-assisted surgery. The state issued an advisory to health care providers about the issue. Intuitive Surgical's stock dropped under $460 per share following those reports, but has since rebounded to around $500. PRICE ACTION: In early afternoon trading, Intuitive Surgical dropped $11.80. or 2.3%, to $494.

Questions About Robotic Hysterectomy

Ever since it was approved by the Food and Drug Administration in 2005, robotic surgery for hysterectomy has been heavily advertised. Surgeons promise that using the da Vinci robotic device will bring better results and an easier recovery, and many hospitals claim that patients will experience less pain and fewer complications, getting back on their feet faster.

The company that makes da Vinci robotic surgery equipment promoted it last May at free health workshops organized by the federal Office on Womens’ Health. On Sunday, the Liberty Science Museum in Jersey City will host its first “Let’s Operate Day,” offering guests “hands-on” practice peering into video monitors and using da Vinci’s robot arms to pick up and manipulate small objects.

The cost of the new technology is rarely mentioned. But last week, a new study that evaluated outcomes in more than a quarter of a million American women raised questions about the manufacturer’s claims. The paper, published in The Journal of the American Medical Association, compared outcomes in 264,758 women who had either laparoscopic or robotically assisted hysterectomy at 441 hospitals between 2007 and 2010. Both methods are minimally invasive and involve smaller incisions than open abdominal surgery.

The researchers found no overall difference in complication rates between the two groups, and no difference in the rates of blood transfusion, even though one of the claims regarding robotic surgery is that it causes less blood loss.

But the researchers did find a big difference in cost. Robotically assisted surgery for hysterectomy costs on average about one-third more than laparoscopic surgery.

“It’s important to separate the marketing from the data,” said Dr. Jason D. Wright, the study’s lead author, an assistant professor of obstetrics and gynecology at Columbia University Medical Center. “For the surgeon, there is a greater degree of movement and control of the instruments and the visualization is better.

“But the ultimate question is, does this change outcomes for patients? This study suggests that there really is not a lot of difference as far as quantifiable outcomes.”

The majority of patients in both groups left the hospital in less than two days, though patients who had robotic surgery were slightly more likely to go home that early: 80 percent went home in less than two days, compared with 75 percent of those who had laparoscopic surgery.

But the cost of robotic surgeries was significantly higher, with a median cost to the hospital of $8,868, compared with $6,679 for laparoscopic hysterectomy. The study did not look at the difference in patients’ bills, but according to Newchoicehealth.com, the average patient price for a laparoscopic hysterectomy ranges from $7,700 in Dallas to $11,600 in Los Angeles.

With laparoscopic surgery — sometimes called keyhole surgery — narrow instruments and a small video camera are inserted through tiny incisions; the surgeon sees the image on a monitor and can cut and sew tissue with the instruments. With robotically assisted surgery, the surgeon sits at a console with a 3-dimensional view of the surgical site, and computer technology translates his or her hand movements into precise, scaled movements of the instruments.

Even without offering clear advantages the proportion of hysterectomies performed robotically has increased rapidly, up to nearly 10 percent of hysterectomies in 2010 from less than 1 percent in 2007, Dr. Wright said. Minimally invasive surgeries for hysterectomies are increasing across the board, he found, even at hospitals not performing robotic surgery.

Dr. Myriam J. Curet, chief medical adviser to Intuitive Surgical, which makes the da Vinci systems, did not dispute the study’s findings, but said the important message was that more women were able to receive minimally invasive surgeries because more options were available.

“That’s good for patients and for the health care system,” Dr. Curet said. Women who are not candidates for laparoscopic surgery might still be candidates for robotically-assisted surgery, she added.

Right now, however, it is not clear how to identify which women would benefit from robotic surgery and which would do well with a less expensive method.

The growing use of robotic surgery in hospitals will continue to drive up health costs, said Joel S. Weissman, of Brigham and Women’s Hospital and a co-author of an editorial published with the study.

“Once you have that robot, the tendency is to use it for all kinds of things, for which it may or may not have great value,” Dr. Weissman said. Studies like this one, he said, demonstrate the waste of health care dollars on “something that costs a lot more and doesn’t offer any added benefit over current treatment options.”

Each year approximately 600,000 American women have hysterectomies, according to the Centers for Disease Control and Prevention. By age 60, one in three American women has had her uterus removed, often along with her ovaries and cervix.

Critics who say far too many hysterectomies are done in the United States worry that all the attention to surgical method distracts from the question of whether patients should be having the surgery at all.

Most hysterectomies are prescribed for conditions that are not life-threatening, and advocates worry that women are not fully informed of the long-term harms, which may include a loss of sexual responsiveness, depression and chronic constipation, and higher risk for osteoporosis and heart disease, said Nora W. Coffey, the founder of the nonprofit Hysterectomy Educational Resources and Services Foundation.

http://well.blogs.nytimes.com/2013/02/25/questions-about-a-robotic-surgery/

Intuitive sales agressive strategy

Here is an extremely interesting report on Intuitive Surgical sales strategy and agressive marketing.

NY TIMES - Salesmen in the Surgical Suite

When Fred E. Taylor arrived at Harrison Medical Center in Silverdale, Wash., for a routine prostatectomy, he expected the best medical care new technology had to offer: robotic surgery, billed as safer, less painful and easier on the body than traditional surgery.

The operation, on Sept. 9, 2008, was supposed to take five hours. But it was marred by a remarkable cascade of complications and dragged on for more than 13 hours, leaving Mr. Taylor, who had been an active 67-year-old retiree, incontinent and with a colostomy bag, and leading to kidney and lung damage, sepsis and a stroke.

Mr. Taylor survived his injuries but died last year. Now, his wife, Josette, is suing Intuitive Surgical Inc., the company that makes the equipment and trained the surgeon to use it. As it turned out, the surgeon, Dr. Scott Bildsten, had never before used the robotic equipment without supervision.

“We are the old school, where you trust the doctor,” said Mrs. Taylor, who noted that her husband’s life was so limited after the operation that he used to cry about being “trapped in this body.”

It is not the first time patients have claimed they were harmed by Intuitive’s robotic surgical equipment, called the da Vinci Surgical System. But the Taylor case, set for trial in April, is unusual. Internal company e-mails, provided to The New York Times by lawyers for the Taylor estate, offer a glimpse into the aggressive tactics used to market high-tech medical devices and raise questions about the quality of training provided to doctors before they use new equipment on patients.

Intuitive, based in Sunnyvale, Calif., declined to comment on the lawsuit but said studies showed that its robotic equipment results in better outcomes than conventional open surgery. “The most objective and therefore best measure of efficacy for all of those involved in training — from Intuitive Surgical, the hospitals, the proctors and the surgeons themselves — is represented in the comparative clinical outcomes of da Vinci surgery,” said Angela Wonson, the company’s vice president for communications.

According to Intuitive, 1,371 hospitals in the United States have purchased a da Vinci system, and many have purchased two. Nearly half a million procedures worldwide were performed robotically last year, including prostatectomies and hysterectomies, among other operations.

A surgeon using the da Vinci system sits at a console with a camera that provides a high-definition, three-dimensional image of the surgical site. He or she manipulates miniaturized instruments; computer and robotic technology translates and scales the surgeon’s hand movements.

Hospitals are responsible for setting the credentialing standards, or training requirements, for physicians who will use the equipment on patients. But internal company e-mails suggest that Intuitive’s sales representatives were intimately involved in the process, presenting themselves as experts and pressing for lower standards in order to ease the training path for busy surgeons, to increase use of the equipment and to drive sales.

In an e-mail dated May 31, 2011, a Western regional sales manager for Intuitive noted that area surgeons had used robotic equipment only five times, although the company’s goal was to see 36 robotic operations performed by the end of June. He urged sales staff to persuade surgeons to switch upcoming cases to robotic ones.

“Don’t let proctoring or credentialing” — shorthand for supervised surgery and hospital certification — “get in our way,” the e-mail said.

In December 2009, a sales representative urged a hospital in Billings, Mont., to ease up on its credentialing requirement, saying in an e-mail that requiring surgeons to do five supervised operations using the robot before going solo was “on the high side” and could have “unintended consequences.” Hospital officials replied, saying, “We will review and most likely will decrease the 5 down to 3.”

Ms. Wonson, the Intuitive spokeswoman, said the company does not get involved in determining who is qualified to operate its robotic equipment, which is the responsibility of the hospitals. “We do not make recommendations,” she said in an e-mail.

Dr. Bildsten was one of six doctors given free training by Intuitive, including one day of hands-on training at the company’s facility in California. He also had done two practice runs on the equipment with a more experienced surgeon before operating on Mr. Taylor, he said in a legal deposition. Still, he said, no one warned him that a patient like Mr. Taylor, who weighed nearly 300 pounds, was not a good candidate for robotic surgery.

He did not respond to telephone messages requesting comment.

Company e-mails submitted in the Taylor case also suggest that members of the sales staff at Intuitive worked diligently to persuade surgeons to choose the da Vinci procedure for patients even when they were planning to use a different method.

In one e-mail on June 28, 2010, a clinical sales director urged the sales team — whose compensation was linked to filling a quarterly quota of operations — to “scrub” doctors’ schedules and get procedures moved up by a few days in order to make the quarterly goal. “Let’s bring it home!” she wrote. “Be sure you scrub all schedules, identify cases on Thursday and Friday that can be moved up.”

On Aug. 9, 2010, a clinical sales director wrote to his team: “Be proactive in finding cases to convert. Be prepared to challenge each trained surgeon every time you see a lap or open case. Be unsatisfied with the thought of ending a day without a converted case.” (“Lap” refers to laparoscopic procedures, an alternate form of minimally invasive surgery.)

The sales representatives were often in the operating rooms, where they offered advice to newly trained surgeons who were having technical difficulties with the robot, according to legal depositions in the Taylor case. The representatives also appear to have had access to the operating room schedules and were urged to “partner” with surgical teams “to review and select appropriate cases,” according to court documents.

On March 3, 2011, a sales representative wrote in an e-mail to his team that he had met with a gynecologic surgeon in Utah who was trained a year earlier but had stopped doing robotic cases. The surgeon subsequently “agreed to convert the next two to da Vinci.”

In depositions, some Intuitive sales representatives defended their involvement, saying that it was important for surgeons to use the robotic system frequently in order to maintain and improve their skills.

The Food and Drug Administration allowed the sale of the da Vinci system in 2000 under a controversial process called “premarket notification,” often used to bring medical devices to market without the rigorous trials of safety and efficacy typically required of new drugs. Manufacturers are able to exempt devices from the rigorous trials by claiming they are similar to existing devices already on the market.

When devices are brought to market this way, the F.D.A. “cannot require training programs as a condition of clearance,” said Synim Rivers, an agency spokeswoman.

Before allowing this type of market clearance, the agency twice asked Intuitive for more information about how doctors would be trained to use company equipment. Intuitive provided details of a 70-item exam for surgeons and a three-day hands-on training protocol.

By 2002, however, the company had revamped its training program, replacing the 70-item exam with a 10-question online quiz and reducing the time spent in hands-on training at Intuitive’s facility to one day.

The largest study to date of robotic hysterectomies has questioned the use of robot-assisted surgery over more conventional forms of minimally invasive surgery. A study published in February in The Journal of the American Medical Association evaluated outcomes in 264,758 women who had laparoscopic or robotically assisted hysterectomy and found no overall difference in complication rates between the two groups.

But the researchers did find that robotically assisted surgery for hysterectomy costs on average about one-third more than laparoscopic surgery.

Last week, Dr. James T. Breeden, the president of the American Congress of Obstetricians and Gynecologists, publicly urged patients “to separate the marketing hype from the reality” when considering a surgical method for hysterectomy. “Just because it’s newer and higher technology,” he said, “doesn’t mean it’s better.”

Robo-surgeon da Vinci faces lawsuits

Robot surgery can mean less blood loss, smaller scars and quicker recovery time, but what if there are complications?

IN 2007, surgeons in Aalst, Belgium, were taken aback when part of a surgical robot's arm broke off inside a patient with prostate cancer. The fracture bent the da Vinci robot's instrument so badly that it could not be removed through the original keyhole incision. That meant the urologists had to enlarge the wound to get the instrument out (Journal of Robotic Surgery, doi.org/crm8p6).

Today more than 2500 of the $1.7 million da Vinci robots are at work in hospitals worldwide, taking part in nearly 1.5 million operations in the past decade. Most patients go home with smaller scars, and the firm that makes da Vinci, Intuitive Surgical of Sunnyvale, California, claims post-operative pain and recovery time are also reduced. But reports of adverse events have risen recently, prompting the US Food and Drug Administration (FDA) to survey surgeons about the system in January. Bloomberg Businessweekreported earlier this month that 10 product liability lawsuits have been filed against da Vinci's makers in the past 14 months.

The lawsuits, which the firm is defending, make for grisly reading – they allege, variously, that da Vinci has caused liver and spleen punctures during heart surgery, rectal damage during a prostate operation, and a vaginal hernia after a hysterectomy. There are also a number of cases of unintended burns from the robot's cauterising tools. The FDA's inquiry, says spokeswoman Synim Rivers, aims to "determine if the rise in reports is a true reflection of problems, or simply an increase due to other factors".

Is there cause for concern? "Rates of adverse events or death for da Vinci surgery have not increased over the past several years," says Intuitive Surgical spokeswoman Lauren Burch, who refused to comment on the lawsuits. "The clinical evidence shows that da Vinci is safer than open surgical alternatives in many common procedures," she says.

The robot aims to offer minimally invasive, highly accurate surgery with a human in control at all times. The surgeon handles the instruments on the robot's four arms from a console with a stereoscopic 3D view of the operation, magnified up to 10 times.

"The console has brilliant, unsurpassed 3D vision, unlike laparoscopic systems with 2D screens," says Ben Challacombe, a consultant urologist at Guy's and St Thomas' NHS Foundation Trust in London. "It also has fantastic control instruments that filter out hand tremors, whereas long laparoscopic tools only enhance tremor." As a regular da Vinci user, Challacombe says the legal issues Intuitive Surgical faces are far more likely to be down to incorrect use by surgeons rather than robot faults.

That view is backed by James Breeden, president of the American Congress of Obstetricians and Gynecologists. "Studies show there is a learning curve with new surgical technologies, during which there is an increased complication rate," he says. And some surgeons only get two days' training on da Vinci.

What's more, healthcare providers are pushing the benefits of robot surgery, Breeden says, advertising less pain, lower blood loss and faster recovery. That drives demand beyond the evidence, he believes. There may not even be good data, claims Breeden, showing "that robotic hysterectomy is even as good as, let alone better than, far less costly minimally invasive alternatives".

This article appeared in print under the headline "Four arms better than two?"

http://www.newscientist.com/article/mg21729105.800-robosurgeon-da-vinci-faces-lawsuits.html

US investigates robotic surgical devices

Shares of Intuitive Surgical fell 11 per cent on Thursday after reports that the US Food and Drug Administration is investigating the safety of its robotic surgical devices.

The FDA said it is surveying a small sample of surgeons who use Intuitive’s da Vinci surgical system. The devices are used in more than 2,000 hospitals around the world and allow surgeons to conduct operations with remote controls and cameras.

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The FDA has received an increase in reports of problems associated with the robotic devices and said it is trying to weigh the risks and benefits of using robotic surgery rather than conventional surgery.

“Since it is difficult to know why the reports have increased, FDA has elected to talk with some surgeons to help in determining if the rise in reports may be a true reflection of problems, or may simply be an increase in reports because of other contributing factors,” Synim Rivers, an FDA spokeswoman, said.

The FDA would not share details of the reports. It said the survey would give a “qualitative” picture of safety of the devices.

The da Vinci system has been used in heart surgeries as well as urological and gynaecological procedures. The device gives doctors a sense of touch and three-dimensional vision during an operation but cannot be programmed to perform surgeries on its own.

Critics of robotic surgery warn that it is risky because doctors are not in direct contact with their patients. However, a study in the Archives of Surgery last year found that individual patient risk factors were more to blame with surgical problems than the robotic technology.

Robotics is a growing area in medicine and Intuitive, which introduced the da Vinci device in 1999, made $2.2bn in revenues last year and $656.6m in net income. The company’s shares fell 11 per cent to $509.89 after Bloomberg News first reported the investigation but rose 3.2 per cent in after-hours trading.

Angela Wonson, an Intuitive spokeswoman, called the inquiry “routine” and said there has not been an increase in deaths or problems related to its devices.

“The clinical evidence shows that da Vinci is safer than open surgical alternatives in many of the common procedures in which it is used,” Ms Wonson said. “We are committed to continuous improvement and, independent of this survey, we are always working to improve both our products and processes.”

Original article: http://www.ft.com/cms/s/0/99a0ca08-81fb-11e2-ae78-00144feabdc0.html#axzz2S2fFlnaN

FDA Investigating Potential Problems with Popular Surgical Robot

The biggest thing in operating rooms these days is a million-dollar, multi-armed robot named da Vinci, used in nearly 400,000 surgeries nationwide last year – triple the number just four years earlier.

But now the high-tech helper is under scrutiny over reports of problems, including several deaths that may be linked with it and the high cost of using the robotic system.

There also have been a few disturbing, freak incidents: a robotic hand that wouldn’t let go of tissue grasped during surgery and a robotic arm hitting a patient in the face as she lay on the operating table.

Is it time to curb the robot enthusiasm?

Some doctors say yes, concerned that the “wow” factor and heavy marketing have boosted use. They argue that there is not enough robust research showing that robotic surgery is at least as good or better than conventional surgeries.

Many U.S. hospitals promote robotic surgery in patient brochures, online and even on highway billboards. Their aim is partly to attract business that helps pay for the costly robot.

The da Vinci is used for operations that include removing prostates, gallbladders and wombs, repairing heart valves, shrinking stomachs and transplanting organs. Its use has increased worldwide, but the system is most popular in the United States.

“We are at the tip of the iceberg. What we thought was impossible 10 years ago is now commonplace,” said Dr. Michael Stifelman, robotic surgery chief at New York University’s Langone Medical Center.

(WATCH: Robotic Legs Move Like a Human)

For surgeons, who control the robot while sitting at a computer screen rather than standing over the patient, these operations can be less tiring. Plus robot hands don’t shake. Advocates say patients sometimes have less bleeding and often are sent home sooner than with conventional laparoscopic surgeries and operations involving large incisions.

But the Food and Drug Administration is looking into a spike in reported problems during robotic surgeries. Earlier this year, the FDA began a survey of surgeons using the robotic system. The agency conducts such surveys of devices routinely, but FDA spokeswoman Synim Rivers said the reason for it now “is the increase in number of reports received” about da Vinci.

Reports filed since early last year include at least five deaths.

Whether there truly are more problems recently is uncertain. Rivers said she couldn’t quantify the increase and that it may simply reflect more awareness among doctors and hospitals about the need to report problems. Doctors aren’t required to report such things; device makers and hospitals are.

It could also reflect wider use. Last year there were 367,000 robot surgeries versus 114,000 in 2008, according to da Vinci’s maker, Intuitive Surgical Inc. of Sunnyvale, Calif.

Da Vinci is the company’s only product, and it’s the only robotic system cleared for soft-tissue surgery by the FDA. There are other robotic devices approved for neurosurgery and orthopedics, among other things.

(MORE: Readers Respond: Your Hospital Bill Nightmares, via CNN iReport)

A search for the company’s name in an FDA database of reported problems related to medical devices brings up 500 reports since Jan. 1, 2012. Many of those came from Intuitive Surgical. The reports include incidents that happened several years ago and some are duplicates. There’s also no proof any of the problems were caused by the robot, and many didn’t injure patients. Reports filed this year include:

- A woman who died during a 2012 hysterectomy when the surgeon-controlled robot accidentally nicked a blood vessel.

- A Chicago man who died in 2007 after spleen surgery.

- A New York man whose colon was allegedly perforated during prostate surgery. Da Vinci’s maker filed that report after seeing a newspaper article about it and said the doctor’s office declined to provide additional information.

- A robotic arm that wouldn’t let go of tissue grasped during colorectal surgery on Jan. 14. “We had to do a total system shutdown to get the grasper to open its jaws,” said the report filed by the hospital. The report said the patient was not injured.

- A robotic arm hit a patient in the face during a hysterectomy. The company filed that report, and said it is unknown if the patient was injured but that the surgeon decided to switch to an open, more invasive operation instead.

Intuitive Surgical filed all but one of those reports.

Complications can occur with any type of surgery, and so far it’s unclear if they are more common in robotic operations, but that’s part of what the FDA is trying to find out.

Intuitive Surgical disputes there’s been a true increase in problems and says the rise reflects a change it made last year in the way it reports problems.

The da Vinci system “has an excellent safety record with over 1.5 million surgeries performed globally, and total adverse event rates have remained low and in line with historical trends,” said company spokeswoman Angela Wonson.

But an upcoming research paper suggests that problems linked with robotic surgery are underreported. They include cases with “catastrophic complications,” said Dr. Martin Makary, a Johns Hopkins surgeon who co-authored the paper.

“The rapid adoption of robotic surgery … has been done by and large without the proper evaluation,” Makary said.

The da Vinci system, on the market since 2000, includes a three- or four-armed robot that surgeons operate with hand controls at a computer system located several feet away from the patient. They see inside the patient’s body through a tiny video camera attached to one of the long robot arms. The other arms are tipped with tiny surgical instruments.

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Robotic operations are similar to conventional laparoscopy, or “keyhole” surgery, which involves small incisions and camera-tipped instruments controlled by the surgeon’s hands, not a robot.

Almost 1,400 U.S. hospitals – nearly 1 out of 4 – have at least one da Vinci system. Each one costs about $1.45 million, plus $100,000 or more a year in service agreements.

The most common robotic operations include prostate removal – about 85 percent of these operations in the U.S. are done with the robot. Da Vinci also is often used for hysterectomies, Wonson said.

Makary says there’s no justification for the skyrocketing increase in robotic surgery, which he attributes to aggressive advertising by the manufacturer and hospitals seeking more patients.

He led a study published in 2011 that found 4 in 10 U.S. hospitals promoted robotic surgery on their websites, often using wording provided by the manufacturer. Some of the claims exaggerated the benefits or had misleading, unproven claims, the study said.

Stifelman, the Langone surgeon, said it makes sense for hospitals to promote robotic surgery and other new technology to, but that it doesn’t mean that it’s the right option for all patients.

“It’s going to be the responsibility of the surgeon … to make sure the patient knows there are lots of options,” and to discuss the risks and benefits, he said.

His hospital expects to do more than 1,200 robotic surgeries this year, versus just 175 in 2008.

For a few select procedures that require operating in small, hard-to-reach areas, robotic surgery may offer advantages over conventional methods, Makary said. Those procedures include head and neck cancer surgery and rectal surgery.

Some surgeons say the robotic method also has advantages for weight-loss surgery on extremely obese patients, whose girth can make hands-on surgery challenging.

“At the console, the operation can be performed effectively and precisely, translating to superior quality,” said Dr. Subhashini Ayloo, a surgeon at the University of Illinois Hospital & Health Sciences System in Chicago.

Ayloo, who uses the da Vinci robot, last year began a study on the effectiveness of doing robotic obesity surgery in patients who need a kidney transplant. Some hospitals won’t do transplants on obese patients with kidney failure because it can be risky. In the study, robotic stomach-shrinking surgery and kidney transplants are done simultaneously. Patients who get both will be compared with a control group getting only robotic kidney transplants.

“We don’t know the results, but so far it’s looking good,” Ayloo said.

Aidee Diaz of Chicago was the first patient and was taken aback when told the dual operation would be done robotically.

“At first you would get scared. Everybody says, `A robot?’ But in the long run that robot does a lot of miracles,” said Diaz, 36.

She has had no complications since her operation last July, has lost 100 pounds and says her new kidney is working well.

Lawsuits in cases that didn’t turn out so well often cite inadequate surgeon training with the robot. These include a malpractice case that ended last year with a $7.5 million jury award for the family of Juan Fernandez, a Chicago man who died in 2007 after robotic spleen surgery. The lawsuit claimed Fernandez’s surgeons accidentally punctured part of his intestines, leading to a fatal infection.

The surgeons argued that Fernandez had a health condition that caused the intestinal damage, but it was the first robot operation for one of the doctors and using the device was overkill for an ordinarily straightforward surgery, said Fernandez’s attorney, Ted McNabola.

McNabola said an expert witness told him it was like “using an 18-wheeler to go the market to get a quart of milk.”

Company spokesman Geoff Curtis said Intuitive Surgical has physician-educators and other trainers who teach surgeons how to use the robot. But they don’t train them how to do specific procedures robotically, he said, and that it’s up to hospitals and surgeons to decide “if and when a surgeon is ready to perform robotic cases.”

A 2010 New England Journal of Medicine essay by a doctor and a health policy analyst said surgeons must do at least 150 procedures to become adept at using the robotic system. But there is no expert consensus on how much training is needed.

New Jersey banker Alexis Grattan did a lot of online research before her gallbladder was removed last month at Hackensack University Medical Center. She said the surgeon’s many years of experience with robotic operations was an important factor. She also had heard that the surgeon was among the first to do the robotic operation with just one small incision in the belly button, instead of four cuts in conventional keyhole surgery.

“I’m 33, and for the rest of my life I’m going to be looking at those scars,” she said.

The operation went smoothly. Grattan was back at work a week later