BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE APC 2

    MDR report key: 21363374 · Received February 12, 2025

    Report

    Report Number
    9610614-2025-00008
    Event Type
    Injury
    Date Received
    February 12, 2025
    Date of Event
    November 16, 2024
    Report Date
    February 12, 2025
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K024047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE APC AND ESU WERE RETURNED. BOTH UNITS WERE THOROUGHLY INSPECTED/TESTED. A TECHNICAL SAFETY CHECK WAS PERFORMED ON THE APC AND ESU (NOTE: THE GENERATOR WAS INSPECTED/TESTED ON 10/11/2024.). THIS INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTIONAL CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK (NOTE: THE LEAKAGE CURRENTS FOR BOTH UNITS WERE WITHIN SPECIFICATIONS PER THE STANDARD.). 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. 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. SINCE NO PROBLEMS WERE FOUND WITH THE ERBE EQUIPMENT, THE CUSTOMER WILL BE ADVISED TO HAVE ALL INVOLVED ACCESSORIES AND NON-ERBE EQUIPMENT CHECKED (E.G., OLYMPUS EQUIPMENT, ETC.) TO ENSURE THAT THEY ARE WORKING PROPERLY. THERE ALSO MAY BE SOME OTHER ENVIRONMENTAL ISSUES IN THE ROOM AFFECTING THE VIDEO MONITOR. HOWEVER, NO DETERMINATION COULD BE MADE AS TO THE CAUSE OF THE REPORTED ISSUE AND 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 ENDOSCOPIC PROCEDURE. THE ERBE SYSTEM WAS USED WITH AN OLYMPUS PROCESSOR AND ENDOSCOPE. NO INFORMATION WAS PROVIDED REGARDING ANY OF THE ACCESSORIES USED IN THE PROCEDURE. ALSO, NO INFORMATION WAS PROVIDED IN REGARDS TO THE SETTINGS USED. DURING THE PROCEDURE, THE OLYMPUS VIDEO SCREEN RANDOMLY BLACKED OUT. A PERFORATION WAS REPORTED BUT NO SURGICAL INTERVENTION WAS NEEDED, BUT THERE WAS HOSPITALIZATION. FINALLY, NO PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846117 ERBE APC 2 ARGON PLASMA COAGULATOR GEI ERBE ELEKTROMEDIZIN GMBH APC 2

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown Hospitalization