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U.S. Department of Health and Human Services

Class 2 Device Recall 8 mm Monopolar Curved Scissors

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 Class 2 Recall
8 mm Monopolar Curved Scissors
see related information
Date Posted May 31, 2013
Recall Status1 Terminated on May 01, 2014
Recall Number Z-1442-2013
Recall Event ID 65216
Premarket Notification
510(K) Number
K050005 
Product Classification System,Surgical,Computer Controlled Instrument - Product Code NAY
Product 8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distributed by: Intuitive Surgical Sunny vale, CA The EndoWrist Monopolar Curved Scissors Instrument is a multiple-use endoscopic instrument utilizing a single use, tip cover accessory, to be used in conjunction with the Intuitive Surgical Endoscopic Instrument Control System.
Code Information Model Numbers 420179-09 and -10 and 400179-09 and -10.
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 has identified a potential for some units of the Monopolar curved Scissors version 09 and 10 instruments to develop very small cracks near the distal end. This may create a pathway for electrosurgical energy to leak to tissue and potentially cause thermal injury.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Intuitive Surgical sent an Urgent Medical Device Recall letter dated May16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that they did not need to quarantine or return the affected device at that time. a Intuitive Surgical representative would contact them to arrange for replacement of the affected product once they became available. In the interim customers were instructed to follow the precautions and warnings outlined in Attachment A in the letter as well as the Instructions for Use. Customers were also asked to ensure all affected personnel were fully informed of the contents of the Recall Notification. The letter should be forwarded to other surgeons and/or managers within their facility. Customers were also asked to complete and return the attached Acknowledgement Form. For further questions customers were instructed to contact Customer Service: North and South America: 800-876-1310 Option 3 Japan: 0120-56-5635 or 003-5575-1362 Korea: 02-3271-3200 Europe, Middle East, Asia and Africa +800 0821 2020 or +41 21 821 2020 For questions regarding this recall call 408-523-2244.
Quantity in Commerce ~132,441 instruments
Distribution Worldwide distribution - USA (nationwide) Foreign Distribution to Argentina, Austria, Australia, Belgium, Brazil, Bulgaria, Canada, China, Chile, Czech Republic, Denmark, Finland, France, Germany, Cyprus- Greece, Egypt, Guadeloupe, Israel, Ireland, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Portugal, Poland, Qatar, Russia, Romania, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Taiwan, Turkey, United Kingdom, Saudi Arabia, Singapore, South Korea, and Venezuela.
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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