BEUDAMED
    FDA Adverse Event Death Summary report: N

    ERBE APC 2

    MDR report key: 1581977 · Received January 8, 2010

    Report

    Report Number
    9610614-2010-00001
    Event Type
    Death
    Date Received
    January 8, 2010
    Date of Event
    October 26, 2009
    Report Date
    January 7, 2010
    Manufacturer
    ERBE ELECTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K024047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE APC/ESU SYSTEM WAS THOROUGHLY INSPECTED/TESTED. A TECHNICAL SAFETY CHECK WAS PERFORMED ON EACH UNIT. THIS INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTION CHECK, A FUNCTION CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. ALSO, THE GAS FLOW RATES WERE MEASURED AND FOUND TO BE WITHIN THEIR ACCEPTABLE RANGES FOR THE APC. ALL FEATURES WERE/ARE FUNCTIONING PROPERLY WITHIN SPECIFICATIONS ON BOTH DEVICES. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORDS (DHR'S) FOR THE APC AND ESU. IN CONCLUSION, NO ERBE EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. BASED UPON THE REPORTED INFO, IT APPEARS THAT COMBUSTIBLE GASES (E.G., METHANE AND/OR HYDROGEN) WERE PRESENT AT SUCH A CONCENTRATION THAT WHEN DIATHERMY WAS APPLIED COMBUSTION OCCURRED. A WARNING IN THE USER MANUALS STATE THAT WHEN USING ELECTROSURGERY IN THE GASTROINTESTINAL TRACT, THERE MUST NOT BE ANY COMBUSTIBLE OR EXPLOSIVE ENDOGENOUS GASES PRESENT. NO TRENDS HAVE BEEN IDENTIFIED WITH THIS SITUATION. ERBE USA, INC. IS NOW CLOSING THIS FILE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT INCIDENT OCCURRED WITH THE ERBE EQUIPMENT [I.E., ERBE SYSTEM; ARGON PLASMA COAGULATOR (APC) MODEL APC 2 WITH AN ELECTROSURGICAL UNIT (ESU/GENERATOR) MODEL VIO 200 D, PART NUMBER 10140-000]. ARGON PLASMA COAGULATION WAS APPLIED TO STOP BLEEDING IN TUMOR TISSUE IN A PALLIATIVE CARE PT. "THE PT WAS ALREADY IN A BAD CONDITION. THE TREATMENT DONE WITH APC WAS TO IMPROVE QUALITY OF LIFE FOR THE REMAINING TIME." UPON DIATHERMY, MOST LIKELY THERE WERE PERFORATIONS/LACERATIONS IN THE STOMACH/ESOPHAGUS DUE TO A COMBUSTION. THE PT EXPIRED THE FOLLOWING DAY. NOTE: THE APC/ESU SYSTEM WAS PROVIDED BY OUR PARENT COMPANY THROUGH A DISTRIBUTOR TO A HOSPITAL IN FOREIGN COUNTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERBE APC 2 ARGON PLASMA COAGULATOR GEI ERBE ELECTROMEDIZIN GMBH APC 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death