Stalling issue in da Vinci robots prompts urgent recall

Surgical patients in Ohio might wish to know that a problem with a $1.5 million cutting-edge surgical device called the da Vinci robot, which has been broadly endorsed by numerous hospitals, has prompted its maker, Intuitive Surgical Inc., to issue an urgent recall on Nov. 11. The recall was intended to alert users of the device of an issue with instrument arm friction, which could cause momentary stalling.

There have been reports of the units stalling in the middle of surgical procedures, and the frequency of these events is reportedly increasing. Studies show that from 2007 to 2011, robot surgeries increased by 400 percent or more in the U.S. Since 2000, there have been approximately 1 million robotic surgeries performed, and 71 patients died after 245 surgeries had complications that were reported to the Food and Drug Administration. However, it is believed that not all complications were reported.

The da Vinci robot is currently in use at three Maine hospitals: Maine Medical Center in Portland, General Medical Center in Augusta, and Eastern Maine Medical Center in Bangor. All of those hospitals stated on Dec. 5 that, in their opinion, the devices are completely safe. The robotic devices will not be removed from the operating rooms where they are currently in use. The manufacturer is simply asking customers to advise health care workers regarding the notification and device inspections.

There are those who believe that a tendency to underreport hospital errors is preventing improvements in health care. If excessive injuries or death happen as a result of defective equipment, it may be possible for patients or their families to file a product liability claim against the manufacturer. If it is proven that the manufacturer knew about a fault but did not issue a recall, it may increase the chances of such claims being successful.

Source: Med City, "FDA investigating surgical robot used at three hospitals after ‘urgent medical recall'", Jackie Farwell, December 06, 2013

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