BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIVEX SYSTEM CONTROL UNIT WITH BUILT IN PUMP

    MDR report key: 7939095 · Received October 5, 2018

    Report

    Report Number
    1220948-2018-00075
    Event Type
    Malfunction
    Date Received
    October 5, 2018
    Date of Event
    September 6, 2018
    Report Date
    October 5, 2018
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    DWQ
    UDI-DI
    00840663106561
    PMA / PMN Number
    K032387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE RECEIVED THE DEVICE FOR EVALUATION. THE BLADES ROTATED PROPERLY WHEN THE RUN BUTTON WAS ENGAGED. THE BLADES ROTATED INTERMITTENTLY AND HESITANTLY WHEN THE WINDOW LOCK BUTTON WAS ENGAGED. UPON DISASSEMBLY OF THE HOUSING, WE NOTICED WATER IN THE MOTOR AND PC BOARD. THE PROBABLE ROOT CAUSE OF THE DEFECT IS A DAMAGE TO THE MOTOR AND THE PC BOARD DUE TO WATER EXPOSURE. WE CURRENTLY HAVE A CORRECTIVE AND PREVENTIVE ACTION (CAPA) OPEN TO ADDRESS THIS ISSUE. THE DEVICE WAS NOT USED IN THE PATIENT. THE ISSUE WAS DETECTED DURING PRE-USE CHECK.

    Description of Event or Problem · 1

    DURING PRE-USE CHECK, THE BLADES OF THE HANDPIECE ROTATED INTERMITTENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778106 TRIVEX SYSTEM CONTROL UNIT WITH BUILT IN PUMP HANDPIECE DWQ LEMAITRE VASCULAR, INC. 00840663106561

    Patients

    Seq Age Sex Outcome Treatment
    1