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FDA Investigating Robotic Surgery Problems

Posted by: Bob Briskman

The Food and Drug Administration (FDA) is investigating a rise in problems with a robotic surgery device, including errors that may constitute medical malpractice.

The robot, called da Vinci, is manufactured by Intuitive Surgical Inc. and was used in close to 400,000 surgeries in 2012, three times as many as in 2008. Now the FDA is investigating problems that include several deaths and incidents of apparent malfunctions.

The million-dollar device is used in operations including repair of heart valves, organ transplants, and removing prostrates and gallbladders. The operations can be less tiring for surgeons, who sit at a computer screen to control the machine. Movements can be more precise with robot arms that do not shake, and doctors report that there is sometimes less bleeding when the device is used.

However, an FDA survey of doctors using da Vinci reveals at least five deaths linked to the machine since early last year. The device is currently the only robotic surgery tool approved by the FDA for soft-tissue surgery.

Reports of problems linked to the device include a woman who died during a hysterectomy when a blood vessel was allegedly nicked by the robot and a man who allegedly suffered a perforated colon during surgery on his prostate. Other incidents include a robotic arm that would not release tissue during surgery, requiring a system shutdown, and a robotic arm that struck a patient in the face.

The FDA investigation is intended to determine whether surgical mistakes using the device have increased. Nearly 1,400 hospitals in the U.S. have at least one da Vinci system.

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