TRIVEX SYSTEM RESECTOR HANDPIECE
Received Mar 8, 2019 · Event occurred Feb 8, 2019
Report 1220948-2019-00023 · MDR key 8405616
Device
Product problems
- Electrical /Electronic Property Problem
- Electrical /Electronic Property Problem
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 AND WE HAVE CONFIRMED THE REPORTED INCIDENT. THE EXTERNAL HOUSING AND POWER CORDS WERE VISUALLY INSPECTED AND WERE FOUND TO BE ACCEPTABLE. WHEN THE HANDPIECE WAS CONNECTED TO THE CONTROL UNIT, THE DRIVE SHAFT IMMEDIATELY STARTED TO ROTATE. THE MOTOR ON THE HANDPIECE AUTOMATICALLY ENGAGED IN THE RUN MODE AND WAS OVER RIDING SIGNALS FROM EITHER BUTTONS IF PRESSED. FURTHER INSPECTION FOUND WATER AND PARTICULATE INSIDE THE CORE TUBE. THE LIKELY ROOT CAUSE OF THE ISSUE IS 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 RESECTOR KEPT SPINNING EVEN AFTER RELEASING THE BUTTON.