BEUDAMED
    FDA Adverse Event Death Summary report: N

    ERBE ICC & APC

    MDR report key: 425727 · Received October 24, 2002

    Report

    Report Number
    425727
    Event Type
    Death
    Date Received
    October 24, 2002
    Date of Event
    October 4, 2002
    Report Date
    October 21, 2002
    Manufacturer
    ERBE USA, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 10/2002 - UNDERWENT EGD WITH ABLATION OF AVM'S USING ERBE APC. THE NEXT DAY - UNDERWENT COLONOSCOPY WITH ABLATION OF CECAL AVM'S URING ERBE APC (SAME UNIT) AT SETTINGS OF 45 WATTS AND IL FLOW. IN THE - PM ABD. X-RAY SHOWED FREE AIR. PATIENT UNDERWENT CECAL RESECTION. 3 DAYS LATER PT CONFUSED, AGITATED. THE NEXT DAY, PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERBE ICC & APC ARGON PLASMA COAGULATOR GEI ERBE USA, INC. APC 300-UL *

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death| O