MalfunctionDWQ
TRIVEX SYSTEM RESECTOR HANDPIECE
Received Sep 1, 2017
Report 1220948-2017-00051 · MDR key 6838833
Device
Product problems
- Disconnection
- Disconnection
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
FROM OUR FOLLOW UP WITH THE HOSPITAL, WE FOUND OUT THAT THE TUBE OF THE DEVICE WAS ACCIDENTLY CUT OFF DURING THE PROCEDURE. AS A RESULT, THE OPERATION HAS TO BE COMPLETED BY PERFORMING A TRADITIONAL STAB PHLEBOTOMY. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THE INCIDENT. THE DEVICE WAS BRAND NEW PRIOR TO THIS PROCEDURE. THE DEVICE WAS TESTED BEFORE THE PROCEDURE AND WAS FOUND TO BE WORKING AS EXPECTED.
Description of Event or Problem
DEVICE STOPPED WORKING DURING THE PROCEDURE.