TRIVEX SYSTEM RESECTOR HANDPIECE
Received Apr 11, 2019 · Event occurred Mar 13, 2019
Report 1220948-2019-00041 · MDR key 8505541
Device
Product problems
- Overheating of Device
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 HOUSING AND POWERCORD WERE VISUALLY INSPECTED AND FOUND TO BE ACCEPTABLE. THE HANDPIECE WAS RAN FOR SEVERAL MINUTES. HOWEVER, WE COULD NOT REPLICATE THE REPORTED DEFECT. HOWEVER, DURING OUR EVALUATION, THE DRIVE SHAFT WAS ROTATING INTERMITTENTLY EVEN AFTER RELEASING THE RUN OR THE WINDOW LOCK BUTTON. UPON DISASSEMBLY, WE OBSERVED WATER INSIDE THE CORE TUBE. THE SEAL HOUSING ALSO HAD VISUAL SIGNS OF HEAT DISCOLORATION WHICH SUGGESTS THAT THE DEVICE WAS OVERHEATED AT SOME POINT. THE ROOT CAUSE WAS DETERMINED TO BE A SEAL FAILURE THAT LED TO WATER INGRESS INTO THE HANDPIECE, WHICH ADVERSELY AFFECTED THE MOTOR FUNCTIONALITY. WE CURRENTLY HAVE A CAPA OPEN TO ADDRESS THIS ISSUE. THE CORRECTIVE ACTION INCLUDES REPAIRS BY REPLACING THE CURRENT SEAL HOUSING WITH A NEW SEAL HOUSING ASSEMBLY, O-RINGS AND SWITCH PCB AND MOTOR IF THERE IS ANY EVIDENCE OF WATER INSIDE THE CORE TUBE. WE BELIEVE THESE CHANGES WILL BETTER PREVENT WATER AND STEAM FROM ENTERING INTO THE INNER COMPONENTS OF THE HANDPIECE. DEVICE WAS NOT USED FOR THE PROCEDURE. PROCEDURE WAS COMPLETED USING ANOTHER HANDPIECE THAT THEY HAD IN STOCK.
Description of Event or Problem
DURING PRE-USE CHECK, THE HANDPIECE WAS OVERHEATING. DEVICE WAS NOT USED FOR THE TIPP PROCEDURE.