TRIVEX SYSTEM RESECTOR HANDPIECE
Received Apr 26, 2018 · Event occurred Feb 7, 2018
Report 1220948-2018-00020 · MDR key 7465194
Device
Product problems
- Device Inoperable
- Device Inoperable
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. HOWEVER, WE WERE UNABLE TO REPLICATE THE DEFECT THAT OCCURRED AT THE USER FACILITY. MDU HOUSING WAS INSPECTED AND WAS FOUND TO BE ACCEPTABLE. MDU WAS FOUND TO BE FUNCTIONING ON ALL SETTINGS AND FUNCTIONS. WE COULD NOT REMOVE THE POWER CABLE FROM THE ENDBELL DUE TO THE CORROSION ON THE ENDBELL. WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE DEFECT SINCE THE DEVICE OPERATED PROPERLY DURING OUR EVALUATION PROCESS. HOWEVER, IT IS POSSIBLE THAT WATER EXPOSURE INTO THE ELECTRICAL COMPONENTS OF THE HANDPIECE COULD HAVE SENT INCORRECT SIGNALS TO THE SCU RESETTING THE DEVICE. WE CURRENTLY HAVE A CORRECTIVE AND PREVENTIVE ACTION (CAPA) OPEN TO ADDRESS THIS ISSUE. THE DEVICE WAS NOT USED IN THE PATIENT AS THE ISSUE WAS DETECTED DURING PRE-USE CHECK. PROCEDURE WAS COMPLETED USING A DIFFERENT HANDPIECE.
Description of Event or Problem
TRIVEX CONTROL UNIT RESETS TO THE DEFAULT SETTINGS WHEN THE HANDPIECE CONNECTS TO THE CONTROL UNIT.