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).
FDA Recall Z-2339-2012 · Posted 2012-09-10
Recalling FirmIntuitive Surgical, Inc.
Recall StatusTerminated
Product CodeNAY
Date Initiated2012-08-09
Date Terminated2012-12-31
Product Quantity11,121 Boxes
Reason for Recall
There is potential for the sterility of the product to be compromised.
Firm 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.
Root Cause
Employee error
Distribution Pattern
Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Canada, and Lebanon
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.