TRIVEX SYSTEM RESECTOR HANDPIECE

Additional Manufacturer Narrative

WE HAVE EVALUATED THE DEVICE AND CONFIRMED THE REPORTED FAILURE. WHEN THE DEVICE WAS PLUGGED IN, IT DID NOT FUNCTION. A FLASHING ORANGE ERROR CODE APPEARED ON THE CONTROL UNIT WARNING USER OF A HIGH CURRENT FLOW THROUGH THE HANDPIECE. UPON DISASSEMBLY OF THE DEVICE, MOTOR WAS FOUND TO HAVE CORROSION. THERE WAS A STRONG DETERGENT SMELL COMING FROM THE DEVICE WHEN THE MOTOR WAS REMOVED FROM THE CORE TUBE. THERE WAS WATER ON THE SEAL HOUSING UNDER THE PCB. THE ROOT CAUSE IS DETERMINED TO BE MOTOR AND PCB BOARD DAMAGE DUE TO WATER INGRESS. IT IS POSSIBLE THAT WATER CONTAMINATION (FROM REPEATED STERILIZATION) AFFECTED THE FUNCTIONALITY OF THE HANDPIECE. WE HAVE ALSO SUBMITTED MANUFACTURER REPORT NUMBER 1220948-2018-00021 AND 1220948-2018-00022 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.