Device 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.
Z-1426-2013
Product summary
- Event
- Event 65072
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,423 consignee
- Official record key
device-enforcement:Z-1426-2013
Official wording
Reason: Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k).
Code information: NA - marketing and promotional only.
Distribution pattern: USA Nationwide distribution
Derived failure modes
-
Unknown
Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k).