TRIVEX SYSTEM CONTROL UNIT WITH BUILT IN PUMP
Received Oct 5, 2018 · Event occurred Sep 6, 2018
Report 1220948-2018-00075 · MDR key 7939095
Device
Product problems
- Failure to Conduct
- Failure to Conduct
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
WE HAVE RECEIVED THE DEVICE FOR EVALUATION. THE BLADES ROTATED PROPERLY WHEN THE RUN BUTTON WAS ENGAGED. THE BLADES ROTATED INTERMITTENTLY AND HESITANTLY WHEN THE WINDOW LOCK BUTTON WAS ENGAGED. UPON DISASSEMBLY OF THE HOUSING, WE NOTICED WATER IN THE MOTOR AND PC BOARD. THE PROBABLE ROOT CAUSE OF THE DEFECT IS A DAMAGE TO THE MOTOR AND THE PC BOARD DUE TO WATER EXPOSURE. WE CURRENTLY HAVE A CORRECTIVE AND PREVENTIVE ACTION (CAPA) OPEN TO ADDRESS THIS ISSUE. THE DEVICE WAS NOT USED IN THE PATIENT. THE ISSUE WAS DETECTED DURING PRE-USE CHECK.
Description of Event or Problem
DURING PRE-USE CHECK, THE BLADES OF THE HANDPIECE ROTATED INTERMITTENTLY.