FDA 483 - Intuitive Surgical, Inc. - May 30, 2013

This FDA Form 483 details observations from an inspection of Intuitive Surgical, Inc. The primary observation is the failure to report four field actions to the FDA's San Francisco District Recall Coordinator. These actions, dated 10/10/2011, 10/13/2011, 10/17/2011, and 01/24/2013, were corrections or removals intended to reduce health risks posed by devices.

Specifically: - **10/10/2011:** A letter regarding proper use of instruments with tip covers and correct generators for monopolar instruments, in response to 134 complaints and 82 Medical Device Reports (MDRs) for arcing through damaged tip covers causing patient injury. - **10/13/2011:** A letter notifying da Vinci clients that the da Vinci surgical systems are not cleared for thyroidectomy indication, which had been promoted by the firm. This action followed 13 complaints and 5 MDRs related to thyroidectomies. - **10/17/2011:** A letter providing information for inspecting instrument cannulas, proper flushing, and transportation of da Vinci systems, following 2 complaints related to flush ports and 17 related to cannulas, some of which were root causes for arcing and patient injuries. -