Recall Z-1426-2013 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
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.
| Date | May 29, 2013 (initiated Oct 13, 2011) |
| Status | Terminated |
| Reason | 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 | No Marketing Application |
| Action | 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 conjunct |
| Quantity | 2,423 consignee |
| Distribution | USA Nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090993 | INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMS, MODELS IS1200, IS2000 AND IS3000 Intuitive Surgical, Inc., Dec 16, 2009 |