Enforcement Report - Week of September 19, 2012
-
Back to Previous Page
Product Detail
| Product Description | 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). |
|---|---|
| Recall Number | Z-2339-2012 |
| Classification | Class II |
| Code Info | 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 |
| Product Distributed Qty | 11,121 Boxes |
| Reason For Recall | There is potential for the sterility of the product to be compromised. |
Event Detail
| Event Id | 62807 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Intuitive Surgical, Inc. |
| City | Sunnyvale |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-08-09 |
| Initial Firm Notification of Consignee or Public | |
| Distribution Pattern | Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Canada, and Lebanon |
-
