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Articles Tagged with Da Vinci Surgical System

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The FDA issued a warning letter to Intuitive Surgical, which hammers the makers of the da Vinci surgical robot for failing to notify the federal regulators about information the company sent to doctors using the robotic surgery machine.

The FDA letter was issued after a FDA inspection between April 1 and May 30 of the company’s production facility. Investigators found that Intuitive Surgical had sent out field correction letters to doctors and hospitals in order to correct or prevent da Vinci problems.  According to federal regulations, the FDA must be informed within 10 working days of such a notification.

One of the notifications appears to show that Intuitive Surgical knew that the da Vinci had problems with electricity arcing from the tools as early as October 2011.

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