MalfunctionDWQ
TRIVEX SYSTEM RESECTOR HANDPIECE
Received Jan 18, 2019 · Event occurred Nov 19, 2019
Report 1220948-2019-00006 · MDR key 8262582
Device
Product problems
- Electrical /Electronic Property Problem
- Electrical /Electronic Property Problem
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
WE HAVE NOT RECEIVED THE DEVICE FOR EVALUATION SINCE THE DEVICE IS STILL AT THE HOSPITAL. HENCE, WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE DEFECT AT THIS TIME. THERE WAS NO IMPACT ON THE PATIENT'S HEALTH AS THE RESULT OF THIS INCIDENT. THE ISSUE WAS DETECTED DURING PRE-USE CHECK.
Description of Event or Problem
HANDPIECE DID NOT OPERATE PROPERLY DURING PRE-USE CHECK. THE RESECTOR ON THE HANDPIECE STOPPED SPINNING AFTER A WHILE AND THE INDICATOR LIGHT FLASHED ORANGE ON THE CONTROL UNIT.