BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIVEX SYSTEM RESECTOR HANDPIECE

    MDR report key: 8039697 · Received November 5, 2018

    Report

    Report Number
    1220948-2018-00096
    Event Type
    Malfunction
    Date Received
    November 5, 2018
    Date of Event
    October 3, 2018
    Report Date
    November 5, 2018
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    DWQ
    UDI-DI
    00840663107391
    PMA / PMN Number
    K032387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE RECEIVED THE DEVICE FOR EVALUATION. THE HOUSING AND POWER CORD WERE VISUALLY INSPECTED AND WERE FOUND TO BE ACCEPTABLE. THE HANDPIECE WAS THEN CONNECTED TO THE CONTROL UNIT AND WAS FURTHER TESTED. THE DRIVE SHAFT ON THE HANDPIECE DID NOT ROTATE INITIALLY WHEN THE RUN BUTTON WAS PRESSED. HOWEVER, WHEN THE RUN BUTTON WAS PRESSED FOR EXTENDED PERIOD OF TIME, THE DRIVE SHAFT KEPT ROTATING EVEN WHEN THE RUN BUTTON WAS RELEASED. WE FOUND SIMILAR ISSUE WHEN PRESSING THE LOCK BUTTON AS THE DRIVE SHAFT KEPT ROTATING EVEN AFTER RELEASING THE LOCK BUTTON. THE DEVICE IS CURRENTLY AWAITING FURTHER EVALUATION. HOWEVER, BASED ON OUR DEVICE EVALUATION PERFORMED SO FAR, WE WERE ABLE TO CONFIRM THE MALFUNCTION WITH THIS DEVICE. WE CURRENTLY HAVE A CORRECTIVE AND PREVENTIVE ACTION (CAPA) OPEN TO ADDRESS THIS ISSUE. THERE WAS NO INJURY TO THE PATIENT. THE MALFUNCTION WAS DETECTED PRIOR TO THE CASE.

    Description of Event or Problem · 1

    DURING PRE-USE CHECK, THE RESECTOR ON THE HANDPIECE DID NOT ROTATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876550 TRIVEX SYSTEM RESECTOR HANDPIECE HANDPIECE DWQ LEMAITRE VASCULAR, INC. 00840663107391

    Patients

    Seq Age Sex Outcome Treatment
    1