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

On July 16, 2013, the FDA issued a Warning Letter to Intuitive Surgical, Inc. following an inspection from April 1 to May 30, 2013. The inspection found that the firm's da Vinci Surgical Systems and accessories were misbranded and adulterated.

The misbranding violations stemmed from the failure to submit written reports to the FDA within 10 working days for corrections or removals initiated to reduce health risks or remedy Act violations, as required by 21 CFR 806.10(b). Specific examples included: 1. An October 2011 field correction regarding Tip Cover Accessory use and generator compatibility, in response to arcing complaints and patient injuries. This was later classified as a Class II recall (Z-1425-2013). 2. An October 2011 field correction notifying clients that da Vinci Systems promoted for thyroidectomy were not cleared for that use, despite complaints and MDRs. This was later classified as a Class II recall (Z-1426-2013). 3. An October 2011 field correction providing information on inspecting instrument cannulas, proper instrument flushing, and system transportation. This was later classified as a Class II recall (Z-1428-2013). 4. A January 2013 field correction with a