TRIVEX SYSTEM RESECTOR HANDPIECE
Received Nov 9, 2018 · Event occurred Oct 8, 2018
Report 1220948-2018-00097 · MDR key 8056675
Device
Product problems
- Failure to Conduct
- Failure to Conduct
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 DEVICE FOR EVALUATION. THE HOUSING AND POWER CORD WERE VISUALLY INSPECTED AND WERE FOUND TO BE ACCEPTABLE. THE HANDPIECE STATUS LIGHT FLASHED GREEN WHEN THE DEVICE WAS CONNECTED TO THE CONTROL UNIT INDICATING AN ISSUE WITH THE HANDPIECE. WHEN THE RUN BUTTON OR THE WINDOW LOCK BUTTON WAS BRIEFLY PRESSED, THE DRIVE SHAFT ROTATED. UPON DISASSEMBLY OF THE HOUSING, WATER WAS OBSERVED INSIDE THE CORE TUBE. THE SWITCH PC BOARD HAD DISCOLORATION AROUND A REED SWITCH. THE ROOT CAUSE OF THE DEFECT WAS DETERMINED TO BE A DAMAGE TO THE PC BOARD DUE TO WATER EXPOSURE. WE CURRENTLY HAVE A CORRECTIVE AND PREVENTIVE ACTION (CAPA) OPEN TO ADDRESS THIS ISSUE. THERE WAS NO INJURY TO THE PATIENT. THE MALFUNCTION WAS DETECTED PRIOR TO THE CASE.
Description of Event or Problem
DURING PRE-USE CHECK, THE RESECTOR ON THE HANDPIECE DID NOT ROTATE.