New York, New York (PRWEB) November 11, 2013
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective drugs and medical devices, notes that, according to a Nov. 11 Bloomberg report, an increasing number of reported deaths, injuries and malfunctions linked to Intuitive Surgical’s da Vinci surgical robot may pressure hospitals to improve training for doctors who perform procedures using the $1.5 million device. This, the Bloomberg article relates, stems from an FDA survey of surgeons that suggests the “complex robot interface was a challenge to master and that physician training was inconsistent.”
At the same time, the U.S. Food and Drug Administration (FDA) received 3,697 adverse event reports for this year through Nov. 3, compared with 1,595 for all of 2012, an FDA official told Bloomberg.
“The FDA data reveals robot-assisted surgeries are resulting in an increase of adverse events. Intuitive Surgical—as well as the hospitals—should consider this as a call to reevaluate current da Vinci training procedures,” says Gary P. Falkowitz, a Managing Attorney at Parker Waichman LLP. “And more importantly, from a patient perspective, it is essential that those undergoing robotic surgery carefully weigh the benefits and risks associated with this type of surgery.”
The doctor survey, released by the FDA on Nov. 8, included 11 surgeons, each of whom has performed between 70 and 600 robot surgeries, Bloomberg reported, noting that the physicians, who weren’t identified, reported the robots have brought about a diverse range of patient problems, including reversible limb palsy, temporary nerve damage, perforated bowels, and peripheral vision loss.
Intuitive has faced scrutiny this year over the marketin
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