Devices

Device Recall EndoWrist One Vessel Sealer, 8MM, IS4000

Model / Serial
PN 480322-04, Lot numbers: S10140730 S10140904 S10141007 S10141103 S10140805 S10140912 S10141009 S10141111 S10140814 S10140916 S10141015 S10141118 S10140824 S10140923 S10141020 S10141125 S10140827 S10141001 S10141028.
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, China, Denmark, Ecuador, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Product Description
EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi IS4000. || The EndoWrist Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Xi Surgical System and the ERBE VIO dV electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument.
Manufacturer
Intuitive Surgical, Inc.
1 Event
- Recall of Device Recall EndoWrist One Vessel Sealer, 8MM, IS4000

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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