BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE APC

    MDR report key: 2836910 · Received November 9, 2012

    Report

    Report Number
    9610614-2012-00018
    Event Type
    Injury
    Date Received
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K963189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED, IT APPEARS THAT COMBUSTIBLE GASSES (E.G., METHANE AND/OR HYDROGEN) WERE AT SUCH A CONCENTRATION THAT WHEN DIATHERMY WAS APPLIED AN EXPLOSION OCCURRED. ALTHOUGH VERY RARE, THE COMPLICATION CAN OCCUR. THEREFORE, THERE IS A WARNING IN THE USER MANUAL INVOLVING THE COMPLICATION AND INSTRUCTION THAT ENDOGENOUS GASES MUST BE REMOVED. NO TRENDS HAVE BEEN IDENTIFIED WITH THIS INCIDENT. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS REPORT.

    Description of Event or Problem · 1

    A PT INCIDENT WAS REPORTED IN A CLINICAL ABSTRACT, "EXPLOSION FROM ARGON CAUTERY DURING PROCTOILEOSCOPY OF A PT WITH A COLECTOMY" (CLINICAL GASTROENTEROLOGY AND HEPATOLOGY 2012;10:1176-1178) INVOLVING ERBE EQUIPMENT [I.E., IN ALL PROBABILITY AN ERBE SYSTEM; ARGON PLASMA COAGULATOR (APC) MODEL APC 300 WITH AN ELECTROSURGICAL UNIT (ESU/GENERATOR) MODEL ICC 200 E/A, PART NUMBER 10128-205; SERIAL NUMBERS UNK]. THE EQUIPMENT SETTINGS WERE APC FORCED MODE (PRESUMABLY), 60 WATTS, 0.8 LITERS/MINUTE GAS FLOW. THE ABSTRACT SUMMARY WAS AS FOLLOWS: "WE REPORT A UNIQUE CASE OF A (B)(6) WOMAN WITH GARDNER'S SYNDROME WHO HAD A SUBTOTAL COLECTOMY WITH ILEOPROCTOSTOMY. SINCE THEN, SHE HAS UNDERGONE 12 UNCOMPLICATED PROCTOILESCOPIES, EACH TIME WITH ARGON PLASMA COAGULATION ABLATION OF SMALL POLYPS WITHOUT ANY BOWEL PREPARATION. HOWEVER, DURING THE MOST RECENT PROCEDURE, WHEN WE ATTEMPTED TO CAUTERIZE SOME RECTAL POLYPS, AN IMMEDIATE EXPLOSION OCCURRED, LEADING TO MULTIPLE RECTAL AND ILEAL PERFORATIONS THAT REQUIRED SURGICAL REPAIR WITH A TEMPORARY END ILEOSTOMY. THIS EVENT SUGGESTS THAT BACTERIAL FERMENTATION OF COLONIC CONTENT OR VISIBLE FECES IS NOT NECESSARY FOR COMBUSTION BECAUSE WE OBSERVED A CAUTERY-RELATED EXPLOSION IN THE ABSENCE OF A COLON. THIS CASE SHOWS THE NEED FOR ADEQUATE BOWEL PREPARATION IF CAUTERY IS TO BE USED, EVEN IN PTS WHO HAVE UNDERGONE A COLECTOMY."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R