BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIVEX SYSTEM RESECTOR HANDPIECE

    MDR report key: 7970585 · Received October 16, 2018

    Report

    Report Number
    1220948-2018-00083
    Event Type
    Malfunction
    Date Received
    October 16, 2018
    Date of Event
    September 16, 2018
    Report Date
    October 16, 2018
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    DWQ
    UDI-DI
    00840663106561
    PMA / PMN Number
    K032387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808916 TRIVEX SYSTEM RESECTOR HANDPIECE VARICOSE VEIN ALBATION SYSTEM DWQ LEMAITRE VASCULAR, INC. 00840663106561

    Patients

    Seq Age Sex Outcome Treatment
    1