BEUDAMED
    FDA Adverse Event Death Summary report: N

    ERBE APC 2

    MDR report key: 2960632 · Received February 6, 2013

    Report

    Report Number
    9610614-2013-00002
    Event Type
    Death
    Date Received
    February 6, 2013
    Date of Event
    January 11, 2013
    Report Date
    February 6, 2013
    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

    AN OFFER WAS MADE TO THE MEDICAL CENTER TO HAVE THE APC/ESU SYSTEM EVALUATED BY ERBE AS WELL AS TO PERFORM ADDITIONAL IN SERVICE TRAINING. ANY FURTHER INFORMATION OR THE RESULTS OF ANY EQUIPMENT EVALUATION WILL BE PROVIDED IN A FOLLOW-UP REPORT, NEVERTHELESS, 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, ERBE PROVIDES A WARNING IN THE USER MANUAL THAT WHEN USING ELECTROSURGERY IN THE GASTROINTESTINAL TRACT, THERE MUST NOT BE ANY COMBUSTIBLE OR EXPLOSIVE ENDOGENOUS GASES PRESENT. IN CONCLUSION, IT IS EXTREMELY IMPORTANT FOR CLINICIANS TO ENSURE PROPER BOWEL PREPARATION. FURTHER IN-SERVICE TRAINING IS BEING PLANNED WITH THE INVOLVED MEDICAL PERSONNEL.

    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 10140-000, SERIAL NUMBER (B)(4)) WAS USED AFTER A POLYPECTOMY. THE SETTINGS WERE APC PULSED, EFFECT 2 AT 25 WATTS. UPON ACTIVATION, A "POP" WAS HEARD INDICATING A POSSIBLE BOWEL EXPLOSION AND A PERFORATION IN AN ELDERLY PATIENT. NO FURTHER DETAILS WERE PROVIDED, HOWEVER THE PATIENT'S FAMILY DECLINED SURGICAL INTERVENTION AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49491 ERBE APC 2 ARGON PLASMA CAOGULATOR GEI ERBE ELEKTROMEDIZIN GMBH APC 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death