Devices

Device Recall 8mm Fenestrated Bipolar Forceps

Model / Serial
Model number: 400205-04; Lot numbers: M10120816 M10120820 M10120903 M10120910 M10120912 M10120921 M10121008 M10121024 M10121120 M10121130 M10121206 M10121213 M10121215 M10130124 M10130131 M10130213 M10130218 M10130222 M10130313 M10130319 M10130402.
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution-USA (nationwide) including the states of AL, CA, CO, FL, IL, KY, MI, MS, NJ, NY, PA, TX, UT, VA, WA, and WI, and the countries of Austria, Australia, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Netherlands, Norway, Qatar, Romania, Spain, Sweden, Switzerland, Taiwan, United Kingdom, Saudi Arabia, Singapore, and Venezuela.
Product Description
8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. || Multiple use electrosurgical endoscopic instruments.
Manufacturer
Intuitive Surgical, Inc.
1 Event
- Recall of Device Recall 8mm Fenestrated Bipolar Forceps

Manufacturer

Intuitive Surgical, Inc.

Manufacturer Address
Intuitive Surgical, Inc., 1266 Kifer Rd Bldg 100, Sunnyvale CA 94086-5304
Manufacturer Parent Company (2017)
Intuitive Surgical Inc
Source
USFDA

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