Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally inv

FDA device recall Z-1426-2013 · posted 2013-05-29 · Terminated

Recall details

Recalling firm

Intuitive Surgical, Inc.

Reason for recall

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

Action taken

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.

Root cause

No Marketing Application

Status

Terminated

Product code

NAY

Quantity affected

2,423 consignee

Distribution

USA Nationwide distribution

Date initiated

2011-10-13

Date posted

2013-05-29

Date terminated

2013-05-30

Location

Sunnyvale, CA

Related 510(k) clearances