TRIVEX SYSTEM RESECTOR HANDPIECE
Received Apr 18, 2018 · Event occurred Mar 15, 2018
Report 1220948-2018-00016 · MDR key 7441576
Device
Product problems
- Device Inoperable
- Device Inoperable
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
WE HAVE RECEIVED AND EVALUATED THE COMPLAINT DEVICE. HOWEVER, WE CANNOT REPLICATE THE REPORTED FAILURE SINCE THE DEVICE WAS FOUND TO BE FUNCTIONING NORMALLY. WHEN THE RUN AND WINDOW LOCK BUTTONS WERE PRESSED, THEY FUNCTIONED AS INTENDED. THE ENDBELL CONNECTOR OF THE CABLE WAS CLEAN WITHOUT ANY SIGNS OF WEAR. WHEN THE UNIT WAS DISSEMBLED, THERE WERE NO SIGNS OF DAMAGE TO THE INNER ASSEMBLY. AT THIS TIME, WE ARE INCONCLUSIVE ABOUT THE ROOT CAUSE OF THE DEFECT SINCE THE DEVICE FUNCTIONED NORMALLY DURING OUR EVALUATION. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT. THE PROCEDURE WAS COMPLETED USING A DIFFERENT HANDPIECE.
Description of Event or Problem
THE HANDPIECE SHUTS OFF DURING THE PROCEDURE.