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Class 2 Device Recall Da Vinci S 8mm Instrument Cannula |
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Date Initiated by Firm |
January 04, 2008 |
Date Posted |
August 06, 2008 |
Recall Status1 |
Terminated 3 on March 31, 2011 |
Recall Number |
Z-1348-2008 |
Recall Event ID |
46890 |
510(K)Number |
K012036
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Product Classification |
Computer Controlled Instrument - Product Code NAY
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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
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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 CA 94086-5206
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For Additional Information Contact |
Mike Yramategui 408-523-2100
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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.
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FDA Determined Cause 2 |
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
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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