BEUDAMED
    FDA Adverse Event Death Summary report: N

    ERBE 300D/APC2

    MDR report key: 541009 · Received August 5, 2004

    Report

    Report Number
    541009
    Event Type
    Death
    Date Received
    August 5, 2004
    Date of Event
    July 28, 2004
    Report Date
    August 5, 2004
    Manufacturer
    ERBE USA INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDER GOING EGD. AVM IDENTIFIED. AS PHYSICIAN STEPPED ON FOOT PEDAL TO DO CAUTERY, AND UNUSUAL SOUND WAS HEARD COMING FROM PT. NOISE WAS DESCRIBED AS "POPPING" AND "EXPLOSION." MONITOR SCREEN WENT DARK, PRESUMABLY FROM COLLAPSE OF STOMACH AS EQUIPMENT CONTINUED TO FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERBE 300D/APC2 ARGON PLASMA COAGULATOR GEI ERBE USA INC. V10300D *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death EGD 2901.