BEUDAMED
    FDA Adverse Event Death Summary report: N

    ERBE APC 2

    MDR report key: 7116516 · Received December 14, 2017

    Report

    Report Number
    9610614-2017-00034
    Event Type
    Death
    Date Received
    December 14, 2017
    Date of Event
    November 23, 2017
    Report Date
    December 14, 2017
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K024047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 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 (NOTE: UNRELATED TO THE REPORTED ISSUE, SOME ROUTINE UPDATE WORK WAS PERFORMED ON THE APC.). 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 EVENTS. BASED UPON THE INFORMATION PROVIDED, MOST LIKELY THERE WERE MANY FACTORS INVOLVED IN THE EVENT. IT WAS REPORTED THAT THE PATIENT WAS EXTREMELY SICK AND THE BOWEL PREP WAS POOR. AS A RESULT, 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, ERBE PROVIDES A WARNING IN THE USER MANUALS THAT WHEN USING ELECTROSURGERY IN THE GASTROINTESTINAL TRACT, THERE MUST NOT BE ANY COMBUSTIBLE OR EXPLOSIVE ENDOGENOUS GASES PRESENT. THE ACCOUNT IS BEING MADE AWARE OF THE FINDINGS. TO FURTHER ADDRESS THE ISSUE, ADDITIONAL IN-SERVICE WORK IS BEING PLANNED WITH THE INVOLVED STAFF AT THE MEDICAL CENTER. 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) WITH AN ELECTROSURGICAL UNIT (ESU/GENERATOR, MODEL VIO 300 D, PART NUMBER 10140-000, SERIAL NUMBER (B)(4)) WAS INVOLVED IN A PATIENT INCIDENT. A COLONOSCOPY WAS PERFORMED TO TREAT ARTERIOVENOUS MALFORMATION (AVM) IN THE RIGHT COLON. THE PATIENT WAS EXTREMELY SICK AND THE BOWEL PREP WAS POOR. IN CONJUNCTION WITH THE EQUIPMENT AN APC INTEGRATED FILTER CIRCUMFERENTIAL PROBE (PART NUMBER 20132-218) WAS USED. THE SETTINGS WERE PULSED APC, EFFECT 2, 15 WATTS WITH A FLOW RATE OF 0.5 LITER PER MINUTE. UPON ACTIVATION, A BOWEL EXPLOSION OCCURRED. THEN, DURING A COLECTOMY TO ADDRESS THE SITUATION, THE PATIENT CODED AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897377 ERBE APC 2 ARGON PLASMA COAGULATOR GEI ERBE ELEKTROMEDIZIN GMBH APC 2

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death