—#117833

Product

Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures, including endoscopic and video assisted procedure that are preferable to conventional (open) procedures that utilize a cervical incision because they leave no visible neck scar.

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K090993
Affected lot / code info: NA - marketing and promotional only.

Why it was recalled

Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k).

Root cause (FDA determination)

No Marketing Application

Action the firm took

Intuitive sent a notification letter on October 17, 2011 by email to all consigness whose email address were on file. Also a copy of the letter was sent by registered mail on February 8, 2012 to all surgeons whose addresses were on file. The letters informed consignees that Intuitive Surgical were in the process of reviewing labeling for the da Vinci System in regard to use for thyroidectomy procedures. During this period, Intuitive will not provide or facilitate any promotional, training, case observations, proctoring or in case procedural support for use of the da Vinci System in conjunction with thyroidectomy procedures. The letters recommend consulting the institution policy regarding use of approved or cleared medical devices for procedures that are not specified in the labeled indication for use. Questions may be directed to customer service at 1-877-408-3872.

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 1266 Kifer Rd, Bldg 100, Sunnyvale, California 94086-5304

Distribution

Distribution pattern: USA Nationwide distribution

Timeline

Recall initiated: 2011-10-13
Posted by FDA: 2013-05-29
Terminated: 2013-05-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #117833. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.