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U.S. Department of Health and Human Services

Class 2 Device Recall da Vinci 5 mm Instrument Cannulae

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 Class 2 Recall
da Vinci 5 mm Instrument Cannulae
see related information
Date Posted June 05, 2013
Recall Status1 Open
Recall Number Z-1463-2013
Recall Event ID 65168
Premarket Notification
510(K) Numbers
K050369  K101743 
Product Classification System,Surgical,Computer Controlled Instrument - Product Code NAY
Product da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical EndoWrist instruments,
Code Information Model number 420011
Recalling Firm/
Manufacturer
Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale, California 94086-5304
For Additional Information Contact Richard Reeves
408-523-2244
Manufacturer Reason
for Recall
Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN 420262).
FDA Determined
Cause 2
TRAINING: Use Error
Action Intuitive Surgical sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 14, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Customer Service at 800-876-1310 for questions regarding this notice.
Quantity in Commerce 2101 consignees
Distribution Worldwide distribution: US (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom.
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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