FT BIPOLAR RESECTION CORD WOLF
Received May 9, 2016
Report 1717344-2016-00398 · MDR key 5642488
Device
Product problems
- Detachment Of Device Component
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
COVIDIEN REFERENCE #: (B)(4). DATE OF INITIAL REPORT: 05/09/2016. DATE OF FOLLOW-UP REPORT: 06/27/2016. VISUAL INVESTIGATION CONFIRMED THE STORZ CONNECTOR WAS MELTED. HIPOT TESTING DID NOT PASS; FURTHER ELECTRICAL TESTING COULD NOT BE COMPLETED DUE TO THE DAMAGE. A DHR REVIEW WAS PERFORMED BY THE SUPPLIER. THIS REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS AND ALL REQUIRED TESTING WAS SUCCESSFULLY COMPLETED PRIOR TO THE SHIPMENT OF THIS LOT. THE ROOT CAUSE OF THE DAMAGE COULD NOT BE CONFIRMED.
Additional Manufacturer Narrative
(B)(4). THE DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
THE CUSTOMER REPORTED THAT 2 GREY LEAD CONNECTORS DETACHED FROM THE CORD WHEN BEING UNPLUGGED FROM UNIT DURING THE PROCEDURE. NO PATIENT INJURY. INITIAL EVALUATION OF THE CORD FOUND THE DEVICE FAILED HIPOT TESTING.