BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIVEX SYSTEM RESECTOR HANDPIECE

    MDR report key: 8165810 · Received December 14, 2018

    Report

    Report Number
    1220948-2018-00109
    Event Type
    Malfunction
    Date Received
    December 14, 2018
    Date of Event
    November 15, 2018
    Report Date
    December 14, 2018
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    DWQ
    UDI-DI
    00840663106561
    PMA / PMN Number
    K032387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE NOT RECEIVED THE DEVICE FOR EVALUATION SINCE THE DEVICE IS STILL AT THE HOSPITAL. HOWEVER, WE HAVE CONFIRMED THE REPORTED INCIDENT BASED ON THE VIDEO OF THE DEFECT THAT WAS PROVIDED TO US BY THE HOSPITAL. THE BLADES KEPT ROTATING SLOWLY EVEN THOUGH THE WINDOW LOCK BUTTON WAS NOT PRESSED. THERE WAS NO IMPACT ON THE PATIENT'S HEALTH AS THE RESULT OF THIS INCIDENT. THE ISSUE WAS DETECTED DURING THE PRE-USE CHECK AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT HANDPIECE IN STOCK.

    Description of Event or Problem · 1

    THE RESECTOR OF THE HANDPIECE KEPT ROTATING ALTHOUGH THE WINDOW LOCK BUTTON WAS NOT PRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003015 TRIVEX SYSTEM RESECTOR HANDPIECE VARICOSE VEIN ALBATION SYSTEM DWQ LEMAITRE VASCULAR, INC. 00840663106561

    Patients

    Seq Age Sex Outcome Treatment
    1