TRIVEX SYSTEM RESECTOR HANDPIECE
Received Oct 28, 2018 · Event occurred Sep 26, 2018
Report 1220948-2018-00088 · MDR key 8011448
Device
Product problems
- Failure to Conduct
- Failure to Conduct
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
WE HAVE RECEIVED THE DEVICE FOR EVALUATION. THE DRIVE SHAFT ROTATED PROPERLY WHEN THE RUN BUTTON WAS PRESSED. THE DRIVE SHAFT ROTATED PROPERLY WHEN THE LOCK BUTTON WAS PRESSED INITIALLY BUT STOPPED ROTATING AFTER FEW SECONDS. FURTHER INSPECTION FOUND A SMALL AMOUNT OF MOISTURE IN THE CORE TUBE AND UNDER THE PC BOARD. THE DRIVE SHAFT ROTATED PROPERLY WHEN THE MOTOR WAS TESTED IN A STANDALONE MODE WHEN EITHER OF THE BUTTONS WERE PRESSED. THE DRIVE SHAFT WAS FOUND TO BE STUCK TO THE BALL BEARING DUE TO CORROSION. THE MOISTURE CAUSED THE BALL BEARING TO CORRODE OVER TIME UNTIL THE MOTOR COULD NOT ROTATE THE DRIVE SHAFT ANYMORE. THE SEAL FAILURE WAS LIKELY DUE TO WEAR FROM REPEATED CLEANING, USE AND STERILIZATION THAT LED TO WATER INGRESS INTO THE INNER COMPONENTS OF THE HANDPIECE THAT INTERMITTENTLY 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 ADDRESS THIS ISSUE. THE ISSUE WAS DETECTED DURING PRE-USE CHECK. PROCEDURE WAS COMPLETED USING A DIFFERENT HANDPIECE.
Description of Event or Problem
DURING PRE-USE CHECK, THE HANDPIECE FAILED TO OPERATE WHEN IT WAS CONNECTED TO THE CONTROL UNIT.