BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE APC 2

    MDR report key: 19095366 · Received April 12, 2024

    Report

    Report Number
    9610614-2024-00026
    Event Type
    Injury
    Date Received
    April 12, 2024
    Date of Event
    April 2, 2024
    Report Date
    April 12, 2024
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K024047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE APC/ESU SYSTEM AND FIAPC PROBE WERE 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. THE INVOLVED FIAPC PROBE WAS FOUND TO BE WORKING PROPERLY. IN ADDITION, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR) FOR THE FIAPC PROBE. IN CONCLUSION, NO ERBE EQUIPMENT OR ACCESSORY PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR ATTRIBUTED TO THE EVENT. THE EVALUATION OF THE SYSTEM'S CHRONOLOGICAL DATA RECORDED DURING THE PROCEDURE REVEALED THAT THERE WERE 30 ACTIVATIONS WITH FORCED APC MODE, EFFECT 1, 30 WATTS AND A GAS FLOW OF 0.8 LITERS/MINUTE. THERE WERE NO ERROR OR WARNING MESSAGES. BASED UPON THE INFORMATION, MOST LIKELY, THERE WERE MANY FACTORS INVOLVED IN THE REPORTED INCIDENT. HOWEVER, THE PATIENT BEING ELDERLY WITH A VERY THIN-WALLED AREA NEEDING TO BE TREATED WERE KEY PATIENT CIRCUMSTANCES INVOLVED IN THE EVENT. NEVERTHELESS, DURING THE INTERVENTIONAL WORK, THE REMAINING TISSUE OF THE BOWL DID NOT STAY INTACT WHICH RESULTED IN THE PERFORATION. FINALLY, 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 200 D, PART NUMBER (P/N) 10140-200, SERIAL NUMBER (B)(6)] SYSTEM WAS INVOLVED IN A PATIENT INCIDENT. THE APC/ESU SYSTEM WAS USED IN A COLONOSCOPY TO ADDRESS ANGIODYSPLASIA IN THE CECUM. THE ESU/APC SYSTEM WAS USED WITH AN ERBE FILTER INTEGRATED ARGON PLASMA COAGULATION (FIAPC) PROBE (P/N 20134-221, AND LOT NUMBER 203425). NO INFORMATION WAS PROVIDED REGARDING ANY OF THE OTHER ACCESSORIES USED IN THE PROCEDURE. DURING THE TREATMENT OF ANGIODYSPLASIA, A PERFORATION OCCURRED. TO ADDRESS THE PERFORATION, A RIGHT HEMICOLECTOMY WAS PERFORMED, AND THE PATIENT WAS HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833054 ERBE APC 2 ARGON PLASMA COAGULATOR GEI ERBE ELEKTROMEDIZIN GMBH APC 2

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Required Intervention| H