TRIVEX SYSTEM RESECTOR HANDPIECE

Additional Manufacturer Narrative

WE HAVE RECEIVED AND EVALUATED THE COMPLAINT DEVICE. THE MDU WAS PLUGGED INTO THE CONTROL UNIT AND THE RUN BUTTON OPERATED ON ALL SETTINGS AND FUNCTIONS. HOWEVER, THE WINDOW LOCK BUTTON DID NOT OPERATE AT ALL. UPON DISSEMBLY OF THE HOUSING, WE OBSERVED EXCESSIVE WATER INGRESS IN THE CORE TUBE AND ON THE UV ADHESIVE OF THE PC BOARD. THE PROBABLE ROOT CAUSE OF THE DEFECT IS A DAMAGE TO THE MOTOR AND THE PC BOARD DUE TO EXCESSIVE WATER EXPOSURE. THE SEAL LIKELY FAILED DUE TO EXCESSIVE WEAR FROM REPEATED CLEANING, USE AND STERILIZATION LEADING TO A WATER INGRESS INTO THE CORE TUBE OF THE MOTOR. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT.

Description of Event or Problem

RESECTOR HANDPIECE STOPPED WORKING DURING THE PROCEDURE.