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U.S. Department of Health and Human Services

Class 2 Device Recall Da Vinci S 8mm Instrument Cannula

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 Class 2 Recall
Da Vinci S 8mm Instrument Cannula
see related information
Date Posted August 06, 2008
Recall Status1 Terminated on March 31, 2011
Recall Number Z-1348-2008
Recall Event ID 46890
Premarket Notification
510(K) Number
Product Classification System,Surgical,Computer Controlled Instrument - Product Code NAY
Product Da Vinci S 8mm Instrument Cannula with outlet for use with the Da Vinci Surgical System; Model IS2000, Part Numbers: 400254-01, 400255-01; Used in endoscopic surgery to establish a port of entry for Intuitive Surgical's EndoWrist Instruments. Product is distributed by Intuitive Surgical, Inc., Sunnyvale, CA
Code Information Lot Numbers: 13730-01-70807, 13793-71106, 13730-02-70807, WI073202, WI074501, WI073201
Recalling Firm/
Manufacturer
Intuitive Surgical, Inc.
950 Kifer Rd
Sunnyvale, California 94086-5206
For Additional Information Contact Mike Yramategui
408-523-2100
Manufacturer Reason
for Recall
(1) Incorrect dimension on Luer on smoke evacuation cannulae not allowing for secure attachment function. (2) Incorrect labeling. External labeling lot number differs from lot number etched on the cannula.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action On 1/4/08, the firm initiated the recall and its notification was via Urgent Device Recall letters explaining the reason for the recall, requesting immediate discontinued use, segregate non-conforming product in a secure area, and a Customer Service Rep will make contact in order to arrange for the retrieval of the material.
Quantity in Commerce 39 units
Distribution Nationwide
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.
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