BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE APC 3

    MDR report key: 18586393 · Received January 26, 2024

    Report

    Report Number
    9610614-2024-00007
    Event Type
    Injury
    Date Received
    January 26, 2024
    Date of Event
    January 9, 2024
    Report Date
    January 26, 2024
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K191234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE APC/ESU SYSTEM WITH THE WATERJET WERE THOROUGHLY INSPECTED/TESTED BY RYMED. 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 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 THE DEVICES. ADDITIONALLY, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORDS FOR THE EQUIPMENT OR THE HYBRIDAPC PROBE. IN CONCLUSION, NO ERBE EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. PER THE STUDY PROTOCOL, ULCER FORMATION WITH BLEEDING IS CONSIDERED AS AN ANTICIPATED ADVERSE DEVICE EFFECT (ADE) ASSOCIATED WITH GMA. 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 3, PART NUMBER (P/N) 10160-000, SERIAL NUMBER (S/N) (B)(6)] SYSTEM WITH A WATERJET MODEL ERBEJET 2 (P/N 10150-000, S/N (B)(6)) WERE INVOLVED IN A PATIENT INCIDENT AFTER A GASTRIC MUCOSA ABLATION (GMA) AS PART OF AN HYBRIDAPC OBESITY STUDY. THE EQUIPMENT WAS USED WITH A HYBRIDAPC PROBE [P/N 20150-015, LOT NUMBER (L/N) WO403073], WATERJET PUMP CARTRIDGE (P/N 20150-301, L/N WO409593), AND NEUTRAL ELECTRODE (NESSY® PLATE 170, P/N 20193-074, L/N 210621-2401). THE ACCESSORIES WERE DISCARDED AFTER THE PROCEDURE; THEREFORE, THEY WERE NOT AVAILABLE FOR AN EXAMINATION. APPROXIMATELY ONE (1) WEEK AFTER THE GMA TREATMENT/PROCEDURE, THE PATIENT HAD UPPER GASTROINTESTINAL BLEEDING WITH MELENA AND HEMATEMESIS AS WELL AS ABDOMINAL PAIN DUE TO THE FORMATION OF AN ULCER. THEN, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION AND TREATED WITH VARIOUS MEDICATIONS (INCLUDING ACID­BLOCKING MEDICATION). THE PATIENT WAS DISCHARGED FOUR (4) DAYS LATER. NO SURGERY WAS PERFORMED DUE TO THE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1899871 ERBE APC 3 ARGON PLASMA COAGULATOR GEI ERBE ELEKTROMEDIZIN GMBH APC 3

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Hospitalization| R