TRIVEX SYSTEM RESECTOR HANDPIECE
Received Nov 20, 2018 · Event occurred Oct 22, 2018
Report 1220948-2018-00099 · MDR key 8091953
Device
Product problems
- Failure to Conduct
- Failure to Conduct
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
WE HAVE RECEIVED THE DEVICE FOR EVALUATION. THE MDU HOUSING AND POWER CORD WERE VISUALLY INSPECTED AND WERE FOUND TO BE ACCEPTABLE. THE DRIVE SHAFT ROTATED SLIGHTLY WHEN THE RUN BUTTON WAS PRESSED BUT DID NOT ROTATE TO THEIR FULL SPEED. WE COULD NOT DISASSEMBLE THE CORE TUBE AT THIS TIME AS ONE OF THE END BELL PINS REQUIRES MACHINING IN ORDER TO BE REMOVED. THE DRIVE SHAFT DID NOT ROTATE WHEN WE TRIED TO ROTATE THE DRIVE SHAFT USING THE FORCE WITH OUR HAND, WHICH INDICATES THAT THE BALL BEARINGS MIGHT HAVE SEIZED IN THIS DEVICE, WHICH COULD HAVE LED TO THIS ISSUE. WE HAVE ALREADY IMPLEMENTED A CORRECTIVE AND PREVENTIVE ACTION (CAPA) TO RESOLVE THIS ISSUE BY REPLACING THE BALL BEARINGS WITH SLIP BEARINGS. THIS DEVICE WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF THESE CHANGES. THERE WAS NO INJURY TO THE PATIENT SINCE THE ISSUE WAS DETECTED DURING PRE-USE CHECK. THE PROCEDURE WAS COMPLETED USING A DIFFERENT HANDPIECE.
Description of Event or Problem
DURING PRE-USE CHECK, THE HANDPIECE FAILED TO OPERATE WHEN IT WAS CONNECTED TO THE CONTROL UNIT.