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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Da Vinci S 8mm Instrument Cannula 		see related information
Date Posted August 06, 2008
Recall Number Z-1348-2008
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
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Mike Yramategui
408-523-2100
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.
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
 
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