BEUDAMED
    FDA Adverse Event Death Summary report: N

    ERBE APC 2

    MDR report key: 19742703 · Received July 15, 2024

    Report

    Report Number
    9610614-2024-00039
    Event Type
    Death
    Date Received
    July 15, 2024
    Date of Event
    June 10, 2024
    Report Date
    July 15, 2024
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K024047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    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 THE APC AND ESU. THIS INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTIONAL 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 THE ARGON PLASMA COAGULATOR AND ELECTROSURGICAL UNIT (NOTE: WHEN REVIEWING THE SYSTEM'S CHRONOLOGICAL DATA, NO ERRORING OCCURRED DURING THE DAY OF THE PROCEDURE. HOWEVER, THE WATTAGE SETTING PER THE DATA WAS 30 WATTS). IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) OF THE UNITS. IN CONCLUSION, NO ERBE EQUIPMENT OR ACCESSORY PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR ATTRIBUTED TO THE EVENT (NOTE: SOME UNRELATED SERVICE WORK WAS PERFORMED ON THE APC.). NO CONCLUSIVE DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE INCIDENT. NO TRENDS HAVE BEEN IDENTIFIED. 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)/ELECTROSURGICAL UNIT [ESU/GENERATOR, MODEL VIO 300 D, PART NUMBER (P/N) 10140-100, SERIAL NUMBER (B)(6) SYSTEM WAS INVOLVED IN A PATIENT INCIDENT. THE APC/ESU SYSTEM WAS USED IN AN ESOPHAGOGASTRODUODENOSCOPY (EGD) AND A COLONOSCOPY TO CONTROL BLEEDING. THE ESU/APC SYSTEM WAS USED WITH AN OLYMPUS SCOPE AND AN FIAPC STRAIGHT FIRE PROBE. NO INFORMATION WAS PROVIDED REGARDING ANY OF THE OTHER ACCESSORIES USED IN THE PROCEDURE. THE REPORTED APC SETTINGS WERE PULSED APC, EFFECT 2 @ 25 WATTS WITH A 0.8 LITERS/MINUTE FLOWRATE. A DUODENAL PERFORATION OCCURRED, AND THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257810 ERBE APC 2 ARGON PLASMA COAGULATOR GEI ERBE ELEKTROMEDIZIN GMBH APC 2

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Death| O