BEUDAMED
    FDA Adverse Event Death Summary report: N

    ERBE APC 2

    MDR report key: 13289243 · Received January 19, 2022

    Report

    Report Number
    9610614-2022-00001
    Event Type
    Death
    Date Received
    January 19, 2022
    Date of Event
    December 4, 2021
    Report Date
    January 19, 2022
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K024047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE APC/ESU SYSTEM WAS RETURNED AND THOROUGHLY INSPECTED/TESTED. A TECHNICAL SAFETY CHECK WAS PERFORMED ON EACH UNIT. THIS INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTIONAL CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. ALL FEATURES WERE/ARE FUNCTIONING PROPERLY WITHIN SPECIFICATIONS ON BOTH DEVICES. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORDS (DHRS) FOR THE APC AND ESU. IN CONCLUSION, NO ERBE EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR ATTRIBUTED TO THE EVENT. BASED UPON THE INFORMATION PROVIDED, IT APPEARS 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 THERE IS A WARNING IN THE ERBE USER MANUALS, "FLAMMABLE ENDOGENOUS GASES IN THE GASTROINTESTINAL TRACT, RISK OF EXPLOSION TO THE PATIENT!, EXTRACT THE GASES BEFORE PERFORMING ELECTROSURGERY OR IRRIGATE WITH CO2". ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ERBE SYSTEM, ARGON PLASMA COAGULATOR (APC) WITH AN ELECTROSURGICAL UNIT (ESU/GENERATOR, MODEL VIO 200 S, PART NUMBER 10140-400, SERIAL NUMBER (B)(4)) WAS INVOLVED IN A PATIENT INCIDENT. THE ERBE APC/ESU SYSTEM WAS USED WITH AN EVIS EXERA III COLONOVIDEOSCOPE, MODEL #CF-H190L AND SERIAL #:(B)(4) IN A SIGMOIDOSCOPY FOR DIAGNOSTIC PURPOSES. AN ERBE RETURN ELECTRODE WAS PLACED ON THE PATIENT'S LEFT LEG. THE APC WAS ACTIVATED TO STOP BLEEDING IN THE INTESTINE. A BANG/EXPLOSION OCCURRED. THE PATIENT WAS THEN TREATED AS AN EMERGENCY, BUT SOON DIED BECAUSE OF THE LARGE PERFORATION CAUSED BY THE "EXPLOSION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038119 ERBE APC 2 ARGON PLASMA COAGULATOR GEI ERBE ELEKTROMEDIZIN GMBH APC 2

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Death