BEUDAMED
    FDA Adverse Event Summary report: N

    MEGADYNE

    MDR report key: 1241879 · Received November 13, 2008

    Report

    Report Number
    1241879
    Date Received
    November 13, 2008
    Date of Event
    November 5, 2008
    Report Date
    November 13, 2008
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    THE COAG TIP GOT TOO HOT, STARTED "BURNING" WHERE THE BLUE INSULATOR AND THE TIP CONNECT, AND BURNED THROUGH THE DRAPE. A NEW COAG TIP WAS OPENED AND USED TO COMPLETE PROCEDURE.====================== MANUFACTURER RESPONSE FOR ELECTROCAUTER TIP, MEGADYNE======================MANUFACTURER PROVIDED RGA# FOR RETURN PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEGADYNE HANDPIECE, ESU GEI MEGADYNE MEDICAL PRODUCTS, INC. 0012 81086

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR