TRIVEX SYSTEM RESECTOR HANDPIECE
Received Nov 5, 2018 · Event occurred Oct 3, 2018
Report 1220948-2018-00096 · MDR key 8039697
Device
Product problems
- Failure to Conduct
- Failure to Conduct
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
WE HAVE RECEIVED THE DEVICE FOR EVALUATION. THE HOUSING AND POWER CORD WERE VISUALLY INSPECTED AND WERE FOUND TO BE ACCEPTABLE. THE HANDPIECE WAS THEN CONNECTED TO THE CONTROL UNIT AND WAS FURTHER TESTED. THE DRIVE SHAFT ON THE HANDPIECE DID NOT ROTATE INITIALLY WHEN THE RUN BUTTON WAS PRESSED. HOWEVER, WHEN THE RUN BUTTON WAS PRESSED FOR EXTENDED PERIOD OF TIME, THE DRIVE SHAFT KEPT ROTATING EVEN WHEN THE RUN BUTTON WAS RELEASED. WE FOUND SIMILAR ISSUE WHEN PRESSING THE LOCK BUTTON AS THE DRIVE SHAFT KEPT ROTATING EVEN AFTER RELEASING THE LOCK BUTTON. THE DEVICE IS CURRENTLY AWAITING FURTHER EVALUATION. HOWEVER, BASED ON OUR DEVICE EVALUATION PERFORMED SO FAR, WE WERE ABLE TO CONFIRM THE MALFUNCTION WITH THIS DEVICE. WE CURRENTLY HAVE A CORRECTIVE AND PREVENTIVE ACTION (CAPA) OPEN TO ADDRESS THIS ISSUE. THERE WAS NO INJURY TO THE PATIENT. THE MALFUNCTION WAS DETECTED PRIOR TO THE CASE.
Description of Event or Problem
DURING PRE-USE CHECK, THE RESECTOR ON THE HANDPIECE DID NOT ROTATE.