TRIVEX SYSTEM RESECTOR HANDPIECE

Additional Manufacturer Narrative

WE HAVE RECEIVED THE DEVICE FOR EVALUATION AND WE WERE ABLE TO CONFIRM THE REPORTED INCIDENT. WHEN THE HANDPIECE WAS CONNECTED TO A CONTROL UNIT, IT RAN FOR A FEW SECONDS BEFORE COMING TO A HALT. THE MDU STATUS LIGHT FLASHED ORANGE AND INTERMITTENTLY FLASHED GREEN INDICATING AN ISSUE WITH THE HANDPIECE. UPON DISASSEMBLY OF THE HOUSING, WE FOUND WATER INSIDE THE CORE TUBE. WHEN THE MOTOR WAS TESTED IN A STANDALONE MODE, IT FAILED TO OPERATE PROPERLY. THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE MOTOR DAMAGE DUE TO WATER INGRESS. IT IS POSSIBLE THAT THE DEVICE HANDLING TECHNIQUE AND IMPROPER STERILIZATION PROCESS AT THE HOSPITAL COULD HAVE CONTRIBUTED TO THIS INCIDENT. A SEAL FAILURE LIKELY DUE TO WEAR FROM REPEATED CLEANING, USE AND STERILIZATION THAT LED TO WATER INGRESS INTO THE INNER COMPONENTS OF THE HANDPIECE AND ADVERSELY AFFECTED THE MOTOR FUNCTIONALITY. OUR IFU STATES NOT TO REMOVE THE CABLE FROM THE HANDPIECE AND SECURE THE CABLE END WITH THE PROTECTIVE CAP DURING STERILIZATION. WE CURRENTLY HAVE A CORRECTIVE AND PREVENTIVE ACTION (CAPA) OPEN TO INVESTIGATE THIS ISSUE. THERE WAS NO INJURY TO THE PATIENT.

Description of Event or Problem

DURING PHLEBECTOMY PROCEDURE, THE BLADE OSCILLATED SLOWLY WHEN THE WINDOW LOCK BUTTON WAS PRESSED. THE LIGHT ON THE CONTROL UNIT FLASHED RED INDICATING AN ISSUE WITH THE HANDPIECE.