TRIVEX SYSTEM RESECTOR HANDPIECE
Received Dec 7, 2017 · Event occurred Nov 6, 2017
Report 1220948-2017-00068 · MDR key 7097753
Device
Product problems
- Device Stops Intermittently
- Device Stops Intermittently
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 COMPLAINT DEVICE FOR EVALUATION. WHEN THE HANDPIECE WAS PLUGGED INTO THE CONTROL UNIT, THE DEVICE HESITATED TO ROTATE FOR 30 SECONDS DESPITE PRESSING THE RUN BUTTON BUT ROTATED AT 1600 RPMS FO A 5 MINUTES LATER ON WITH NO FURTHER ISSUE. HOWEVER, WHEN THE RUN BUTTON ON THE HANDPIECE WAS PRESSED INTERMITTENTLY, THE MDU STATUS LIGHT ON CONTROL UNIT WOULD FLASH GREEN INDICATING A FAILURE IN THE MDU'S MOTOR UNIT. ALSO, THE BLADE WOULD ROTATE 180 DEGREES BEFORE COMING TO A COMPLETE STOP. THE MOTOR WAS TESTED SEPARATELY AND FAILED FUNCTIONALITY TESTING. THEREFORE, MOTOR FAILURE WAS THE ROOT CAUSE LIKELY FROM AGE AND EXCESSIVE WORN AND TEAR FROM REPEATED USE. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS ISSUE.
Description of Event or Problem
THE BUTTON FOR POSITIONING THE RESECTOR BLADE DID NOT WORK PROPERLY. IT WAS DIFFICULT FOR THE PHYSICIAN TO POSITION THE BLADE CORRECTLY SINCE THE BLADE ROTATED DESPITE RELEASING THE RUN BUTTON.