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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 Recall
Intuitive da Vinci S
see related information
Date Posted January 31, 2008
Recall Status1 Terminated on August 27, 2008
Recall Number Z-0669-2008
Recall Event ID 46160
Premarket Notification
510(K) Number
K050369 
Product Classification System,Surgical,Computer Controlled Instrument - 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/
Manufacturer
Intuitive Surgical, Inc.
950 Kifer Rd
Sunnyvale, California 94086-5206
For Additional Information Contact Mike Yramategui
408-523-2100
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
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 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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