FDA Closes Out Intuitive Surgical’s Warning on Field Corrections

The FDA has closed out a 2013 warning letter to Intuitive Surgical related to unreported field corrections.

The agency evaluated the company's corrective actions and determined it had addressed the violations. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of the corrections, the April 25 closeout letter says.

In the July 16, 2013, warning letter, the FDA provided four examples of product corrections that Sunnyvale, Calif., company did not report to the agency. Among them was a 2011 correction involving letters to customers with advice on the proper use of a surgical system tip cover accessory. The correction came in response to complaints and medical device reports about patient injuries caused by arcing through damaged tip covers.

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