Sunnyvale, CAIntuitive Surgery, the company that makes an instrument that goes with the da Vinci robot, sent an urgent device notification (May 8, 2013) to hospitals regarding a “potential issue” with its device.
The instrument in question, EndoWrist Monopolar Curved Scissors, also known as Hot Shears, could develop small, invisible cracks, or “micro cracks” and cause a leak of electricity that can burn patients, as first reported by CNBC.
Intuitive Surgical says it has received one complaint of injury, and that a subsequent analysis didn't indicate energy leakage. The company also said there is “no confirmed evidence of patient injury attributable to this issue” and it is not recalling the device. A replacement product, however, would be available in two to four weeks. The FDA has been notified.
This isn’t the first problem facing the da Vinci robot. Many plaintiffs have previously filed da Vinci robot lawsuits, alleging internal organ burns suffered from the device. As well, Intuitive Surgery is currently on trial as a defendant in Washington State: the company is accused of improperly training surgeons in the use of the da Vinci surgical robot (Estate of Fred E. Taylor v. Intuitive Surgical Inc. 09-2-03136-5, Superior Court, Port Orchard, Wash.). (It is the first of about a dozen da Vinci lawsuits in the US to go to trial, according to Bloomberg.)
Further, the da Vinci robot has recently come under fire regarding the cost-effectiveness of robotic surgery compared to noninvasive surgery done by hand. The da Vinci robot was used in about 400,000 surgeries in the US in 2012, according to USA Today.(For more information about the da Vinci robot, view the CNBC documentary)
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