BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE APC 300

    MDR report key: 393700 · Received May 8, 2002

    Report

    Report Number
    9610614-2002-00009
    Event Type
    Injury
    Date Received
    May 8, 2002
    Date of Event
    April 12, 2002
    Report Date
    May 8, 2002
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THAT DURING A COLONOSCOPY TO REMOVE ARTERIOVENOUS MALFORMATIONS (AVMS) WITH THE EQUIPMENT [I.E., ERBE SYSTEM; ARGON PLASMA COAGULATOR (APC) MODEL APC 300 WITH AN ELECTROSURGICAL GENERATOR W/ENDOCUT & ARGON MODEL ICC 200 E/A (P.N.: 10128-205) A PT'S ASCENDING COLON WALL WAS PERFORATED. THE SETTINGS WERE 50 WATTS POWER WITH A 0.9 LPM ARGON FLOW RATE. SURGERY WAS REQUIRED (RIGHT HEMICOLECTOMY) TO REPAIR THE COLON AND THE PT IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERBE APC 300 ARGON PLASMA COAGULATOR SYSTEM GEI ERBE ELEKTROMEDIZIN GMBH APC 300 *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening| R