TRIVEX SYSTEM RESECTOR HANDPIECE
Received Aug 22, 2019 · Event occurred Jul 23, 2019
Report 1220948-2019-00111 · MDR key 8923141
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. DRIVE FORK ROTATED HESITANTLY WHEN THE RUN OR THE WINDOW LOCK BUTTON WAS PRESSED. UPON DISASSEMBLY, WE NOTED A WIRE HAD BEEN DISCONNECTED FROM ITS ENDBELL'S PIN. WE NOTED WATER INGRESS INSIDE THE CORE TUBE WHICH COULD HAVE CONTRIBUTED TO THIS DEVICE FAILURE. THE DEVICE APPEARED TO HAVE BEEN DISASSEMBLED BY SOMEONE AT THE CUSTOMER LOCATION WITH AN ATTEMPT TO REPAIR. WE HAVE IMPLEMENTED A CORRECTIVE AND PREVENTIVE ACTION (CAPA) TO ADDRESS THIS ISSUE. BASED ON OUR INVESTIGATION, WE HAVE UPDATED THE DESIGN OF THE HANDPIECE WATER SEALS, WHICH WILL BETTER PREVENT WATER AND STEAM FROM ENTERING INTO THE INNER COMPONENTS OF THE HANDPIECE. THE ISSUE WAS DETECTED DURING PRE-USE CHECK. DEVICE WAS NOT USED IN THE PATIENT.
Description of Event or Problem
DURING PRE-USE CHECK, THE BLADES OF THE RESECTOR DID NOT SPIN.