TRIVEX SYSTEM RESECTOR HANDPIECE

Additional Manufacturer Narrative

WE HAVE RECEIVED AND EVALUATED THE COMPLAINT DEVICE. DURING OUR INITIAL EVALUATION, WHEN THE HANDPIECE WAS CONNECTED TO THE SYSTEM CONTROL UNIT, IT OPERATED AS EXPECTED. THE HANDPIECE INITIALLY FUNCTIONED AT ALL SPEEDS AND SETTINGS BUT RUNNING THE HANDPIECE FOR AN EXTENDED PERIOD OF TIME AT THE LOWER SPEEDS CAUSED THE MDU'S DRIVE SHAFT TO ROTATE INCORRECTLY. THE ROTATION APPEARED TO HESITATE OR STALL WHICH CAUSED THE MDU'S STATUS LIGHT TO FLASH GREEN OR ORANGE DEPENDING ON THE ERROR CONDITION DETECTED BY THE SCU. THERE WAS NO GAP FOUND BETWEEN THE OUTER TUBE'S END AND THE INNER BLADE. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT. WE BECAME AWARE OF THIS INCIDENT AT THE SAME TIME AS OUR REPORT 1220948-2017-00027. IT IS THE SUBSEQUENT REUSE OF THE SAME DEVICE AFTER STERILIZATION. DEVICE WAS SOLD TO THE HOSPITAL ON JUNE 2016. DEVICES ARE MULTI-USE AND CAN BE RE-USED AFTER STERILIZATION. FROM OUR INITIAL INVESTIGATION, WE FOUND THAT THE ROOT CAUSE OF THIS ISSUE IS LIKELY DUE TO THE WEAR IN THE MOTOR BEARING AFTER MULTIPLE USES. IF ADDITIONAL INFORMATION IS AVAILABLE, A FOLLOW-UP REPORT WILL BE SUPPLIED.

Description of Event or Problem

THE RESECTOR BLADE KEPT GETTING CLOGGED AND JAMMED WITH THE VEIN PARTIALLY IN IT DURING PHLEBECTOMY. THE VEIN APPEARED TO GET STUCK IN THE THIN PLATE BETWEEN THE CUTTING ELEMENT OF THE RESECTOR BLADE AND THE OUTER SHELL OF THE RESECTOR BLADE WITHIN WHICH THE CUTTING BLADE OSCILLATES.