BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE APC 2

    MDR report key: 3894049 · Received June 13, 2014

    Report

    Report Number
    9610614-2014-00006
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 16, 2014
    Report Date
    June 13, 2014
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K024047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS EVALUATED AT THE CUSTOMER'S FACILITY. THE UNITS WERE THOROUGHLY INSPECTED/TESTED. SPECIFICALLY, A TECHNICAL SAFETY CHECK WAS PERFORMED ON EACH UNIT. THIS INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTION CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. ALSO, THE GAS FLOW RATES WERE MEASURED FOR THE APC. ALL EQUIPMENT OUTPUTS WERE FOUND TO BE WITHIN SPECIFICATION. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORDS (DHRS) FOR THE APC AND ESU. IN CONCLUSION, NO EQUIPMENT RELATED ISSUE WAS FOUND THAT WOULD HAVE CAUSED OR ATTRIBUTED TO THE EVENT. IT APPEARS THAT COMBUSTIBLE GASES (E.G., METHANE AND/OR HYDROGEN) WERE AT SUCH A CONCENTRATION IN THE BOWEL THAT WHEN DIATHERMY WAS APPLIED AN EXPLOSION OCCURRED. ALTHOUGH VERY RARE THE COMPLICATION CAN OCCUR. THEREFORE, A "FIRE/EXPLOSION" SECTION IN THE USER MANUALS OF THE EQUIPMENT INCLUDES THE DANGER OF FLAMMABLE ENDOGENOUS GASES IN THE GASTROINTESTINAL TRACT. THE ACCOUNT IS BEING MADE AWARE OF THE FINDINGS. TO FURTHER ADDRESS THE ISSUE, ADDITIONAL IN-SERVICE WORK WAS OFFERED TO THE INVOLVED MEDICAL STAFF. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ERBE SYSTEM; ARGON PLASMA COAGULATOR (APC) MODEL APC 2 WITH AN ELECTROSURGICAL GENERATOR MODEL VIO 300 D (PART NUMBER 10140-100, SERIAL NUMBER (B)(4)) WAS USED IN A PROCEDURE TO TREAT ARTERIOVENOUS MALFORMATIONS (AVMS). THE SETTINGS WERE PULSED APC, EFFECT 2 AT 15 WATTS. UPON ACTIVATION, A "POP" WAS HEARD INDICATING A POSSIBLE BOWEL EXPLOSION. THREE (3) PERFORATIONS WERE DETECTED IN THE SMALL BOWEL APPROXIMATELY 40 CM FROM THE IGNITION SOURCE. TO ADDRESS THE PERFORATIONS, THE PATIENT'S BOWEL WAS RESECTIONED AND THE PATIENT IS NOW RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351399 ERBE APC 2 ARGON PLASMA COAGULATOR GEI ERBE ELEKTROMEDIZIN GMBH APC 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention