Device product
Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery. For use when a rigid endoscopic instrument for grasping and/or dissecting if soft tissue is determined to be appropriate by the surgeon. Monopolar electrosurgical current can be used for coagulation and/or cutting.
Z-0886-2013
Product summary
- Event
- Event 64357
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22,500
- Official record key
device-enforcement:Z-0886-2013
Official wording
Reason: Addendum to the Instructions for Use. The addendum emphasizes the warnings and precautions already contained in the device's IFU and also provides additional warnings and precautions that are applicable to the use of electrosurgical equipment in health care facility environments.
Code information: Catalogue No. 600-290. All lots distributed since 2004.
Distribution pattern: Worldwide Distribution - USA Nationwide including Canada.
Derived failure modes
-
Unknown
Addendum to the Instructions for Use. The addendum emphasizes the warnings and precautions already contained in the device's IFU and also provides additional warnings and precautions that are applicable to the use of electrosurgical equipment in health care facility environments.