BEUDAMED
    FDA Adverse Event Death Summary report: N

    ERBE APC 2

    MDR report key: 18463386 · Received January 8, 2024

    Report

    Report Number
    9610614-2024-00003
    Event Type
    Death
    Date Received
    January 8, 2024
    Date of Event
    January 12, 2021
    Report Date
    January 8, 2024
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K024047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 02/11/21, THE APC/ESU SYSTEM WAS RETURNED AND THOROUGHLY INSPECTED/TESTED BY THE CANADIAN DISTRIBUTOR, VANTAGE ENDOSCOPY (NOTE: AT THAT TIME, THEY WERE NOT INFORMED BY THE HOSPITAL THAT THE DEVICES WERE INVOLVED IN A PATIENT INCIDENT.). 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 OR FLOW 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 WITH OXYGEN) WERE AT SUCH A CONCENTRATION IN THE BOWEL THAT WHEN DIATHERMY WAS APPLIED AN EXPLOSION OCCURRED. THERE ARE WARNINGS IN THE ERBE APC USER MANUAL AND NOTES ON USE FOR ERBE'S APC APPLICATION DEVICES ADDRESSING THIS TYPE OF SITUATION. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    PER A LAWSUIT IN CANADA (B)(6) AND FROM INFORMATION GATHER THROUGH THE CANADIAN DISTRIBUTOR, THE PATIENT CAME TO (B)(6) HOSPITAL ON (B)(6) 2021 WITH RECTAL BLEEDING. ON (B)(6) 2021, AN ENDOSCOPIC EXAMINATION REVEALED THAT SHE HAD A 3MM BLEEDING POLYP. THE ATTENDING PHYSICIAN DECIDED TO REMOVE THE POLYP WITH AN APC APPLICATION AND STOP THE BLEEDING. THE ERBE ARGON PLASMA COAGULATOR (APC)/ELECTROSURGICAL UNIT (ESU) SYSTEM USED WAS AN APC WITH AN ESU (MODEL VIO 300 D, PART NUMBER 10140-000, SERIAL NUMBER (B)(6). WHEN THE EQUIPMENT WAS ACTIVATED, AN EXPLOSION OCCURRED IN THE BOWEL. THE SUBSEQUENT VISUAL INSPECTION REVEALED A 15-20 MM LONG, DEEP TEAR IN THE AFFECTED SECTION OF THE BOWEL. DESPITE AN EMERGENCY COLECTOMY, ADMINISTRATION OF BLOOD, RESUSCITATION AND INTENSIVE MEDICAL TREATMENT, THE PATIENT DIED ON (B)(6) 2021 IN HEMORRHAGIC SHOCK. THE INCIDENT WAS NOT REPORTED BY THE HOSPITAL TO THE IMPORTER/DISTRIBUTOR (VANTAGE ENDOSCOPY) OR TO ERBE AT THAT TIME. ERBE WAS ONLY INFORMED OF THIS EVENT THROUGH THE LIGATION DOCUMENTATION RECEIVED ON 12/11/2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599886 ERBE APC 2 ARGON PLASMA COAGULATOR GEI ERBE ELEKTROMEDIZIN GMBH APC 2

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Required Intervention| H| L| D