Monday, July 15, 2013

FDA claims 30 da Vinci robot devices not properly tested.

Bloomberg News (7/12, Tirrell, Larkin) reported that the FDA said that Intuitive Surgical Inc., which makes da Vinci Surgical System robots, told its customers that “30 devices may not have been tested properly” In an Urgent Device Correction notice, Intuitive said the class 2 recall “affects Intuitive’s da Vinci Si Vision System Cart, Si Surgeon Side Cart, Instrument Control Box and Dual Camera Controller.” The devices were re-tested on site after the company discovered that “one piece of testing equipment wasn’t recording results properly,” a spokeswoman said. Bloomberg News noted that earlier this year “US regulators were surveying surgeons about the robots following a rise in adverse event reports that include as many as 70 deaths since 2009.”

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