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Da Vinci Lawsuit News: FDA Suggests Robotic Surgery Training May be Influenced by Rising Number of Da Vinci Robotic Surgery Complications, Reports Wright & Schulte
Date:11/12/2013

ing to Wright & Schulte, the report raises questions about the efficacy of current training for physicians and the need for a more standardized training approach. The firm’s Da Vinci lawsuit lawyers agree with the assertions of Robert Sweet, a medical training expert at the University of Minnesota told Bloomberg that standardized training “is a systemic problem.”

Wright & Schulte LLC also found validity in the comments of Jeff Berkley, CEO of Mimic Technologies Inc., a company that makes simulators used for robot device training, who told Bloomberg that robotic training “has been the wild, wild west for a long, long time,” though with more patients filing Da Vinci robot lawsuits he said, hospitals are realizing “they have to get their act together and start focusing on training.”

Bloomberg reports that so far this year, the FDA has received 3,697 adverse event reports regarding Da Vinci robot complications, compared to only 1,595 reports for all of 2012. Earlier this year, the FDA issued a warning letter to Da Vinci robot maker Intuitive Surgical Inc., after finding the company had failed to report adverse events and failed to make specific device corrections. (fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm363260.htm, FDA, July 16, 2013)

Last month, Intuitive reported that about 50 Da Vinci robotic surgery lawsuits had been filed on behalf of individuals who claim they sustained serious injuries during Da Vinci robot-assisted surgeries. While earlier this year, the American Congress of Obstetrics & Gynecologists (ACOG) said there was a lack of evidence showing improved patient outcomes for robot-assisted hysterectomies, and advised that robotic surgeries should not used as a first choice for most women who need to have a hysterectomy. (sec.gov/Archives/edgar/data/1035267/000119312513297410/d551118d10q.htm; SEC, July 22, 2013) [acog.org/About_ACOG/News_Room/News_Releases/2013/Statement_on_Robotic_Surgery, ACOG, March 14
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1. Deaths, Injuries and Malfunctions Tied to da Vinci Surgical Robot May Prompt Hospitals to Improve Training for Doctors Using Device, Notes Parker Waichman LLP
2. Da Vinci Robot Lawsuit News: Bernstein Liebhard LLP Notes FDA Finding that Robotic Surgery Complications Linked to da Vinci Robot Doubled in Past Year
3. da Vinci Lawsuit News: Rottenstein Law Group LLP Comments on News That Surgical Robot Problems Not Reported to FDA
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8. Two Surgeons Working with Intuitive Surgical to Promote the da Vinci Surgical Robot ‘Downplayed Risks,’ Reports the Orange County Register; Parker Waichman LLP Responds
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10. Study Says Using the da Vinci Surgical Robot for a Hysterectomy Fails to Cut Complications and May Raise Pneumonia Risk, Notes Parker Waichman LLP
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