BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEGADYNE ULTRA VAC

    MDR report key: 6721464 · Received July 14, 2017

    Report

    Report Number
    MW5071054
    Event Type
    Malfunction
    Date Received
    July 14, 2017
    Date of Event
    July 14, 2017
    Report Date
    July 14, 2017
    Manufacturer
    I.C. MEDICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN THE I.C. MEDICAL, INC. MEGADYNE ULTRA VAC CAUTERY PENCIL ACTIVATION BUTTON WAS DEPRESSED, THE BUTTON STUCK AND CONTINUED TO DELIVER A CURRENT EVEN AFTER THE SURGEON RELEASED HIS FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493935 MEGADYNE ULTRA VAC SUCTION CAUTERY GEI I.C. MEDICAL, INC. 2110-10 6392

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR