TRIVEX SYSTEM RESECTOR HANDPIECE

Additional Manufacturer Narrative

WE HAVE RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. HOWEVER, WE WERE UNABLE TO CONFIRM THE REPORTED INCIDENT AS WE WERE UNABLE TO REPLICATE THE REPORTED INCIDENT DURING OUR EVALUATION. THE HOUSING AND POWER CORD WERE VISUALLY INSPECTED AND WERE FOUND ACCEPTABLE. THE INDICATOR ON THE CONTROL UNIT PROPERLY FLASHED SOLID GREEN WHEN THE HANDPIECE WAS CONNECTED TO THE CONTROL UNIT. THE DEVICE PROPERLY FUNCTIONED ON ALL SETTINGS AND SPEED. UPON DISASSEMBLY, WATER WAS OBSERVED INSIDE THE CORE TUBE. THE ROOT CAUSE WAS DETERMINED TO BE A SEAL FAILURE THAT LED TO WATER INGRESS INTO THE HANDPIECE, WHICH INTERMITTENTLY AFFECTED THE MOTOR FUNCTIONALITY. WE CURRENTLY HAVE A CAPA OPEN TO ADDRESS THIS ISSUE. THE CORRECTIVE ACTION INCLUDES REPAIRS BY REPLACING THE CURRENT SEAL HOUSING WITH A NEW SEAL HOUSING ASSEMBLY, O-RINGS AND SWITCH PCB AND MOTOR IF THERE IS ANY EVIDENCE OF WATER INSIDE THE CORE TUBE. WE BELIEVE THESE CHANGES WILL BETTER PREVENT WATER AND STEAM FROM ENTERING INTO THE INNER COMPONENTS OF THE HANDPIECE. PROCEDURE WAS COMPLETED USING ANOTHER HANDPIECE THAT THEY HAD IN STOCK.

Description of Event or Problem

DURING TIPP ( TRANSILLUMINATED POWERED PHLEBECTOMY) PROCEDURE, THE RESECTOR FAILED TO ROTATE. SO, THE PROCEDURE WAS COMPLETELY USING A DIFFERENT HANDPIECE. THERE WAS NO INJURY OR ANY ADVERSE EVENT TO THE PATIENT AS THE RESULT OF THIS INCIDENT.