TRIVEX SYSTEM RESECTOR HANDPIECE

Additional Manufacturer Narrative

WE HAVE EVALUATED THE DEVICE AND CONFIRMED THE REPORTED FAILURE. WHEN THE UNIT WAS INITIALLY PLUGGED IN, THE RUN FEATURE WORKED BUT STRAINED AND STUTTERED. THE WINDOW LOCK FEATURE FUNCTIONED INTERMITTENTLY. WHEN THE INNER ASSEMBLY WAS REMOVED FROM THE CORE TUBE, WE OBSERVED WATER AND CORROSION ON THE METAL CORE. IT WAS ALSO NOTED THAT ONE OF THE WIRE THAT JOINS THE PCB TO THE MOTOR HAD SEPARATED. THERE WAS WATER DAMAGE TO THE SURFACE OF THE PCB BOARD. WATER WAS OBSERVED UNDER THE PCB BOARD. WHEN THE SHAFT WAS REMOVED, THE SPLIT RETAINING RING WAS MISSING, ALLOWING THE LIP SEALS AND SPACER TO TRAVEL ALONG THE SHAFT. THE ROOT CAUSE IS DETERMINED TO BE MOTOR AND PCB BOARD DAMAGE DUE TO WATER INGRESS ON THE BOARD COUPLED WITH LOOSE CONNECTION. WE HAVE ALSO SUBMITTED MANUFACTURER REPORT NUMBER 1220948-2018-00022 AND 1220948-2018-00023 FOR THE INCIDENTS THAT OCCURRED WITH TWO OTHER HANDPIECES AT THE SAME HOSPITAL AND DURING THE SAME CASE. OUR DEVICE EVALUATION FOUND WATER EXPOSURE INTO THE INNER COMPONENTS IN ALL THREE DEVICES REPORTED TO BE MALFUNCTIONING BY THE HOSPITAL. IT IS POSSIBLE THAT DEVICE HANDLING TECHNIQUE AND IMPROPER STERILIZATION PROCESS AT THE HOSPITAL COULD HAVE CONTRIBUTED TO THIS INCIDENT. OUR IFU STATES NOT TO REMOVE THE CABLE FROM THE HANDPIECE AND SECURE THE CABLE END WITH THE PROTECTIVE CAP DURING STERILIZATION. DEVICE WAS NOT USED IN THE PATIENT. THE ISSUE WAS DETECTED DURING PRE-USE CHECK.

Description of Event or Problem

RESECTOR HANDPIECE DID NOT WORK PROPERLY DURING PRE-USE CHECK.