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.”

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