TRIVEX SYSTEM RESECTOR HANDPIECE

Additional Manufacturer Narrative

WE HAVE RECEIVED THE DEVICE FOR EVALUATION AND WE WERE ABLE TO CONFIRM THE REPORTED INCIDENT. THE RESECTOR DID NOT ROTATE AT ALL WHEN THE WINDOW LOCK BUTTON WAS PRESSED. THE RESECTOR ROTATED INTERMITTENTLY WHEN THE RUN BUTTON WAS PRESSED. WE NOTED THE HANDPIECE CABLE AND THE OUTSIDE OF THE ENDBELL CONNECTOR TO BE WET AND OBSERVED DEBRIS AROUND THE BEZEL AREA. THE WET CONNECTOR CABLE AND OUTER END BELL FACE INDICATES THAT THE CORD WAS REMOVED DURING CLEANING AND STERILIZATION. THE MOTOR WAS NOTED TO BE CORRODED. THE O-RINGS ON THE DISTAL END OF THE SEAL HOUSING WAS OBSERVED TO BE DAMAGED. IT IS POSSIBLE THAT THE WATER ENTERED INSIDE THE HANDPIECE DUE TO THIS FAILURE CORRODING THE MOTOR. THE PROBABLE ROOT CAUSE OF THE DEFECT IS A DAMAGE TO THE MOTOR AND THE PC BOARD DUE TO WATER EXPOSURE DURING STERILIZATION. OUR IFU STATES NOT TO REMOVE THE CABLE FROM THE HANDPIECE AND SECURE THE CABLE END WITH THE PROTECTIVE CAP DURING STERILIZATION. WE ALSO CURRENTLY HAVE A CORRECTIVE AND PREVENTIVE ACTION (CAPA) OPEN TO ADDRESS THIS ISSUE. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT.

Description of Event or Problem

DURING PRE-USE CHECK, THE HANDPIECE FAILED TO WORK PROPERLY.