BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE APC 2

    MDR report key: 16983014 · Received May 23, 2023

    Report

    Report Number
    9610614-2023-00030
    Event Type
    Malfunction
    Date Received
    May 23, 2023
    Date of Event
    April 5, 2023
    Report Date
    May 23, 2023
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K024047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A TECHNICAL SAFETY CHECK WAS PERFORMED ON THE INVOLVED ESU UNIT. THIS INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTIONAL CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. ALL FEATURES WERE/ARE FUNCTIONING PROPERLY WITHIN SPECIFICATIONS ON THE DEVICE. THE APC NOR THE INVOLVED APC PROBE WERE MADE AVAILABLE TO ERBE FOR INSPECTING/TESTING. NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORDS (DHRS) FOR THE APC, ESU, OR APC PROBE. THE INFORMATION PROVIDED WAS VERY LIMITED TO DETERMINE A ROOT CAUSE. NONETHELESS, THERE ARE MANY POSSIBLE CAUSES FOR THE REPORTED DEFECT (HOLE) FOUND ON THE PROXIMAL END OF THE PROBE (NOTE: REUSABLE APC PROBES ARE NOT AVAILABLE/CLEARED FOR DISTRIBUTION IN THE U.S.). THE DAMAGE TO THE ACCESSORY COULD HAVE BEEN THE RESULT OF IMPROPER PROCESSING, MISHANDLING (BEING KINKED), ADVANCE WEAR, THERMAL OVERLOAD, ETC. NEVERTHELESS, THE NOTES ON USE FOR THE REUSABLE APC PROBE EXPLICITLY STATES THAT THE PRODUCT MUST BE PROTECTED FROM ANY MECHANICAL DAMAGE AND THAT THE INSULATION MUST BE CHECKED FOR DAMAGE BEFORE EACH USE. IN THE EVENT OF A DEFECT, THE APC PROBE MUST NOT BE USED. 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 S, PART NUMBER (P/N) 10140-300, SERIAL NUMBER (B)(6) SYSTEM WAS INVOLVED IN A PATIENT INCIDENT. THE APC/ESU SYSTEM WAS USED TO REMOVE MULTIPLE POLYPS IN THE COLON. A REUSABLE ERBE APC PROBE (PART NUMBER 20132-177, LOT NUMBER 1021) WAS USED IN THE PROCEDURE. NO INFORMATION WAS PROVIDED REGARDING OTHER EQUIPMENT OR ACCESSORIES USED. ADDITIONALLY, THE EQUIPMENT SETTINGS (E.G., MODES, EFFECTS, ETC.) USED IN THE PROCEDURE WERE ALSO NOT CONVEYED TO ERBE. NEVERTHELESS, UPON AN ARGON PLASMA APPLICATION, A BURN/NECROSIS OF APPROXIMATELY 5 MM X 5 MM OCCURRED ON THE MUCOSA OF THE COLON. THEREFORE, AS A PART OF THE INTERVENTIONAL WORK, HEMOSTASIS WAS APPLIED TO THE AREA TO ADDRESS THE ISSUE. AFTER THE PROCEDURE, AN EXAMINATION OF THE PROBE REVEALED A SMALL DEFECT ABOUT 1 CM PROXIMAL TO THE DISTAL END. THE REUSABLE APC PROBE WAS THEN DISPOSED OF AND WAS NOT PROVIDED TO ERBE FOR AN INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1410065 ERBE APC 2 ARGON PLASMA COAGULATOR GEI ERBE ELEKTROMEDIZIN GMBH APC 2

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention