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U.S. Department of Health and Human Services

Class 2 Device Recall Intuitive da Vinci S

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  Class 2 Device Recall Intuitive da Vinci S see related information
Date Initiated by Firm November 19, 2007
Date Posted January 31, 2008
Recall Status1 Terminated 3 on August 27, 2008
Recall Number Z-0669-2008
Recall Event ID 46160
510(K)Number K050369  
Product Classification Cannula - Product Code NAY
Product Intuitive brand da Vinci S, 5 mm Instrument Cannula
Model/Part Number: 420011-02, Product is manufactured and distributed by Intuitive Surgical , 950 Kifer Road,
Sunnyvale, CA
Code Information Lot Numbers Affected:  SA070902, SA071101, and SA071401   
Recalling Firm/
Intuitive Surgical, Inc.
950 Kifer Rd
Sunnyvale CA 94086-5206
For Additional Information Contact Mike Yramategui
Manufacturer Reason
for Recall
Sharp Edges: the 5mm Cannula may have a sharp edge on the inner diameter of the Cannula. The defective cannulae may cause particulate shavings to be skive (scraping) from the instrument shafts during surgery.
FDA Determined
Cause 2
Action On 11/19/07, the firm issued Urgent Device Recall Notification letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.
Quantity in Commerce 89 units
Distribution Worldwide: USA including states of AZ, CA, CT, DC, GA, lA, MI, MN, NC, NJ, NV, OH, PA, SD, TX, and VA and country of Hong Kong
Total Product Life Cycle TPLC Device Report

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.
510(K) Database 510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.