BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ERBE

    MDR report key: 23082969 · Received September 18, 2025

    Report

    Report Number
    23082969
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Date of Event
    September 8, 2025
    Report Date
    September 15, 2025
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    UDI-DI
    04050147014022
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FROM STAFF: MEDICAL DEVICE MALFUNCTION, ARGON PLASMA COAGULATOR TIP CAME OFF, FIAPC SONDE M. FILTER 2200C ITEM REF# 20132-218, LOT# 212660. THE TIP OF THE ARGON PLASMA COAGULATOR OFF VERY EASILY WHILE CLEANING IT. FOR REFERENCE, THE TIP OF THE COAGULATOR IS 1/4 THE SIZE OF AN AVERAGE PIN HEAD. SAID TIP CAME OFF WITH ITS WIRING WHILE CLEANING IT IN THE MIDDLE OF SURGERY. TIP IS CURRENTLY NOT INCLUDED IN THE SUBMITTED DEVICE BECAUSE THE SAID PART HAS TISSUE IN IT AND WAS BEST TO HAVE IT DISCARDED. AS SOON AS THE TIP WAS NOTICED TO HAVE COME OFF, DEVICE WAS PLUGGED OUT AND QUICKLY REPLACED WITH A NEW ONE. NO HARM WAS DONE DUE TO SAID INCIDENT BUT MAY POTENTIALLY PUT PATIENT AT RISK IF IT HAPPENS AGAIN INTRAOPERATIVELY WHILE DOING SAID COAGULATION IF IT MAY HAPPEN AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2640286 ERBE ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES GEI ERBE ELEKTROMEDIZIN GMBH 20132-218 212660 04050147014022

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female