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Da Vinci Surgical Robot Lawsuit Update: Parker Waichman LLP Comments on FDA Warning Letter Sent to Intuitive Surgical Noting da Vinci Surgical Robot Deficiencies
Date:7/19/2013

New York, New York (PRWEB) July 19, 2013

Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, notes that the U.S. Food and Drug Administration (FDA) sent a warning letter to Intuitive Surgical on July 17 after inspections by the agency in April and May found deficiencies, including the company’s failure to adequately report device corrections and patient adverse events, according to a July 19 Bloomberg report. The da Vinci surgical robot’s safety and cost effectiveness have also fallen under scrutiny, Bloomberg added, noting in the same report that, in February, U.S. regulators had started surveying surgeons about the robots on the heels of a rise in adverse event reports that included as many as 70 deaths since 2009.

“The FDA has clearly noticed and acknowledged Intuitive’s failure to disclose an increase in adverse events,” said Gary Falkowitz, Managing Attorney from Parker Waichman LLP. “Failing to disclose such issues is concerning.”

The Bloomberg report also noted that Intuitive’s surgical robotic system, used in more than 1,300 hospitals, is the company’s flagship product and has been the subject of negligence lawsuits alleging that patients were injured during surgeries with the device. Cancer surgery, hysterectomies and gall bladder removals are among the main procedures performed with the assistance of the surgical robot, which cost about $1.5 million each, the report added.

On March 14th, the American Congress of Obstetricians and Gynecologists (ACOG) issued a '/>"/>

Source: PRWeb
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