TRIVEX SYSTEM RESECTOR HANDPIECE
Received Feb 28, 2019 · Event occurred Jan 29, 2019
Report 1220948-2019-00016 · MDR key 8379085
Device
Product problems
- Electrical /Electronic Property Problem
- Electrical /Electronic Property Problem
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. THE STATUS LIGHT ON THE CONTROL UNIT INITIALLY FLASHED SOLID GREEN WHEN THE HANDPIECE WAS CONNECTED INTO THE CONTROL UNIT. THE STATUS LIGHT ON THE CONTROL UNIT FLASHED ORANGE WHEN THE RUN BUTTON WAS PRESSED INDICATING AN ISSUE WITH THE HANDPIECE AND THE DRIVE SHAFT WAS OBSERVED TO ROTATE HESITANTLY . THE STATUS LIGHT ON THE CONTROL UNIT ALSO FLASHED GREEN WHEN THE LOCK BUTTON WAS PRESSED AND THE DRIVE SHAFT ROTATED HESITANTLY. THE ISSUE WAS DETECTED DURING PRE-USE CHECK. HANDPIECE WAS NOT USED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A DIFFERENT HANDPIECE.
Description of Event or Problem
HANDPIECE DID OPERATE DURING PRE-USE CHECK.