FDA Recall Terminated

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.

Recall: Z-1426-2013 · Initiated October 13, 2011

Recall

Recall Number: Z-1426-2013
Event Number: 65072
Firm: Intuitive Surgical, Inc.
FEI Number: 3001675293
Product Code: NAY
Status: Terminated
Root Cause: No Marketing Application
Initiated: October 13, 2011
Posted: May 29, 2013
Terminated: May 30, 2013
Address: 1266 Kifer Rd, Bldg 100, Sunnyvale, CA, 94086-5304

Description

Reason

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

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 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.

Distribution

USA Nationwide distribution

Quantity

2,423 consignee