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U.S. Department of Health and Human Services

Class 2 Device Recall daVinci TORS Indication of Use

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 Class 2 Recall
daVinci TORS Indication of Use
see related information
Date Posted May 29, 2013
Recall Status1 Terminated on May 30, 2013
Recall Number Z-1426-2013
Recall Event ID 65072
Premarket Notification
510(K) Number
K090993 
Product Classification System,Surgical,Computer Controlled Instrument - Product Code NAY
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.
Code Information NA - marketing and promotional only.
Recalling Firm/
Manufacturer
Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale, California 94086-5304
For Additional Information Contact Richard Reeves
408-523-2244
Manufacturer 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).
FDA Determined
Cause 2
PREMARKET APPROVAL: 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 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.
Quantity in Commerce 2,423 consignee
Distribution USA Nationwide distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.
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