BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIVEX SYSTEM RESECTOR HANDPIECE

    MDR report key: 8122019 · Received December 1, 2018

    Report

    Report Number
    1220948-2018-00102
    Event Type
    Malfunction
    Date Received
    December 1, 2018
    Date of Event
    October 30, 2018
    Report Date
    November 30, 2018
    Manufacturer
    LEMAITRE VASCULAR, INC.
    Product Code
    DWQ
    UDI-DI
    00840663106561
    PMA / PMN Number
    K032387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE NOT RECEIVED THE DEVICE FOR EVALUATION SINCE THE DEVICE IS STILL AT THE HOSPITAL. HENCE, WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE DEFECT. 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. THE DEVICE WAS NON-FUNCTIONAL AND THEREFORE THE MALFUNCTION WAS DETECTED PRIOR TO THE CASE. THERE HAS BEEN NO SERIOUS INJURY (SECTION 2.13) NOR WOULD THE MALFUNCTION RESULT IN A DEATH OR SERIOUS INJURY IF IT WAS TO REOCCUR I.E THE DEVICE NEVER FUNCTIONED AT ANY POINT OF THE CASE AND THEREFORE THE PATIENT WAS NEVER EXPOSED OR POTENTIALLY EXPOSED, TO THE DEVICE. HOWEVER, WE HAVE DECIDED TO REPORT THE INCIDENT SINCE OUR EVALUATION WAS BASED ON THE REPORTED DEFECT FROM OUR SALES REP. AND THE USER AT THE HOSPITAL RATHER THAN OUR HANDS-ON EVALUATION WITH THIS DEFECTIVE DEVICE ITSELF. OUR SALES REP. REACHED OUT TO THE TEAM INVOLVED IN THE SURGERY FOR ADDITIONAL INFORMATION. HOWEVER, NEITHER THE SURGEON OR THE TECH WAS AVAILABLE FOR DISCUSSION ON THIS CASE AT THE TIME.

    Description of Event or Problem · 1

    THE CONTROL UNIT DISPLAYED AN ERROR CODE WHEN THE RESECTOR WAS PLUGGED INTO THE CONTROL UNIT. THE CONTROL UNIT WAS FLASHING ORANGE UPON CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962575 TRIVEX SYSTEM RESECTOR HANDPIECE VARICOSE VEIN ALBATION SYSTEM DWQ LEMAITRE VASCULAR, INC. 00840663106561

    Patients

    Seq Age Sex Outcome Treatment
    1