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U.S. Department of Health and Human Services

Class 2 Device Recall Tip Cover, Accessory

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 Class 2 Recall
Tip Cover, Accessory
see related information
Date Posted September 10, 2012
Recall Status1 Terminated on December 31, 2012
Recall Number Z-2339-2012
Recall Event ID 62807
Premarket Notification
510(K) Number
Product Classification System,Surgical,Computer Controlled Instrument - Product Code NAY
Product Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10. The intended use of the Tip Cover Accessory is to provide dielectric insulation over a section of the Monopolar Curved Scissor instrument so that RF energy is only available at the scissor blades. The Monopolar Curved Scissors are intended for endoscopic manipulation of tissue, including: cutting, blunt and sharp dissection, electrocautery. This accessory is to be used with the Intuitive Surgical Endoscopic Instrument Control Systems (da Vinci, da Vinci S and da Vinci Si Surgical Systems Models IS1200, 12000, ISSOQO).
Code Information Model No. 400180-12 Lot No: M10120601 M10120430 M10120329 M10120312 M10111214 M10120516 M10120426 M10120321 M10120208 M10111208 M10120510 M10120419 M10120317 M10120207 M10111201 M10120507 M10120413 M10120315 M10120130 M10111028
Recalling Firm/
Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale, California 94086-5304
Manufacturer Reason
for Recall
There is potential for the sterility of the product to be compromised.
FDA Determined
Cause 2
TRAINING: Employee Error
Action Intuitive Surgical sent a "MEDICAL DEVICE CORRECTION" letter dated August 9, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. An Acknowledgement Form was included for customers to complete and return via fax to (408) 716-3040. Contact Customer Service at 1-800-876-1310 for questions regarding this recall.
Quantity in Commerce 11,121 Boxes
Distribution Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Canada, and Lebanon
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.