BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE APC 3

    MDR report key: 18737924 · Received February 20, 2024

    Report

    Report Number
    9610614-2024-00012
    Event Type
    Injury
    Date Received
    February 20, 2024
    Date of Event
    January 23, 2024
    Report Date
    February 20, 2024
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K191234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE APC, ESU, AND WATERJET WERE THOROUGHLY INSPECTED/TESTED. 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, A POWER OUTPUT CHECK, ETC. ALL FEATURES WERE/ARE FUNCTIONING PROPERLY WITHIN SPECIFICATIONS FOR EACH OF THE DEVICES. ADDITIONALLY, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORDS (DHRS) OF THE UNITS AND THE HYBRIDAPC PROBE. IN CONCLUSION, NO EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE RISK OF ULCER FORMATION AND ULCER BLEEDING AFTER A GMA PROCEDURE IS KNOWN AND DESCRIBED IN THE STUDY PROTOCOL. THIS IS A METHOD-RELATED RISK AND IS NOT ASSOCIATED WITH A DEFECT IN THE DEVICES OR INSTRUMENTS. 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) ] WAS INVOLVED IN A PATIENT INCIDENT UPON A TREATMENT AS PART OF THE GASTRIC MUCOSAL ABLATION (GMA) STUDY, "SAFETY AND FEASIBILITY OF HYBRIDAPC FOR GASTRIC MUCOSAL ABLATION IN THE MANAGEMENT OF PATIENTS WITH CLASS ILL OBESITY (HAPC-GMA BRA)". THE EQUIPMENT WAS USED WITH AN ERBE HYBRIDAPC PROBE (P/N 20150-015, LOT NUMBER WO382353) AND ERBE WATERJET PUMP CARTRIDGE (INFORMATION NOT PROVIDED). THE INITIAL GMA TREATMENT/PROCEDURE OCCURRED ON (B)(6) 2024. IN EARLY FEBRUARY, THE PATIENT WENT TO THE EMERGENCY ROOM OF THE HOSPITAL WITH POST-INTERVENTIONAL BLEEDING. ENDOSCOPIC DIAGNOSTICS REVEALED A VENTRICULAR ULCER WITH VISIBLE VASCULAR STUMP (TYPE FORREST ILA HEMORRHAGE). THE VESSEL WAS CLOSED WITH A METAL CLIP. AFTER THE ENDOSCOPY, THE PATIENT WAS MONITORED AS AN INPATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398159 ERBE APC 3 ARGON PLASMA COAGULATION UNIT GEI ERBE ELEKTROMEDIZIN GMBH APC 3

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention| H