The Food and Drug Administration says Intuitive Surgical, which makes the da Vinci surgical robot, broke procedures when it warned customers about problems with the robot without first alerting regulators.
In what is known as a "483" letter following a recent inspection the FDA said that between January 2010 and December 2011 Intuitive received 134 complaints and filed 83 medical device reports related to "tip cover issues."
According to the FDA, in October 2011 Intuitive sent customers a letter with "suggestions and recommendations for the proper use of instruments with tip covers and for the correct generators that should be used with monopolar instruments."
The "correction," the FDA said, was in response to complaints regarding "arcing through damaged tip covers that caused patient injury."
Arcing occurs when electrical currents jump inside someone during a surgery. Arcing was a focus of CNBC's Investigations Inc.'s documentary, "The da Vinci Debate."
An FDA 483 letter is a notice to a company that FDA inspectors have found a possible violation of federal regulations. The letters are not a final determination by the agency. The company can respond to and contest the findings of such letters.
In a statement issued to CNBC Tuesday, Intuitive said the corrective letter it sent to customers during the period cited by the FDA "was a reiteration of existing FDA-cleared labeling that reminded users on proper use. The observation is that we didn't report that we sent the letter. We documented it as a non-reportable field action to the FDA because it did not change any of the FDA cleared labeling. Over the last several years, we have maintained consistent and ongoing communication with the FDA to include tip cover."
In May CNBC reported that Intuitive issued an "urgent medical device notification" alerting hospitals that it had "identified a potential issue" with "monopolar curved scissors" that could cause internal burns.
This article has been revised to clarify the nature of the FDA's letter to Intuitive Surgical.
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