BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 534188 · Received June 15, 2004

    Report

    Report Number
    534188
    Event Type
    Other
    Date Received
    June 15, 2004
    Date of Event
    May 10, 2004
    Report Date
    June 2, 2004
    Manufacturer
    ELMED, INC.
    Product Code
    HET
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON USING LAPARSCOPIC CAUTERY HOOK AND INSERTED THROUGH PORT. THE FOOT SWITCH WAS ACTIVATED WITH NO CAUTERY INSIDE THE ABDOMEN. ON INSPECTION THE CORD WITH ELECTRODE POST DISCONNECTED AND WAS LYING ON THE PTS ABDOMEN. A SMALL BURN TO THE SKIN WAS NOTED. THE ELECTRODE POST WAS RECONNECTED TO THE HOOK AND SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * LAPAROSCOPIC CAUTERY HOOK HET ELMED, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other