BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBOTOM ICC 350

    MDR report key: 14460987 · Received May 20, 2022

    Report

    Report Number
    9610614-2022-00016
    Event Type
    Injury
    Date Received
    May 20, 2022
    Date of Event
    May 2, 2022
    Report Date
    May 20, 2022
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K933002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ESU WAS THOROUGHLY INSPECTED/TESTED. THE UNIT WAS FOUND NOT TO BE FUNCTIONING AS INTENDED. SPECIFICALLY, THE SPARK MONITOR WAS DEFECTIVE. ADDITIONALLY, THE NE SOCKET WAS LOOSE AND WORN OUT. REPAIRS OF THE UNIT ARE NO LONGER POSSIBLE, AS THE EQUIPMENT (SINCE 2008) IS NO LONGER BEING SERVICED (NOTE: THE EQUIPMENT IS WELL BEYOND ITS USEFUL LIFE). THERE ARE MANY POSSIBLE CAUSES OF THE EVENT. FOR EXAMPLES, A DEFECTIVE INSTRUMENT (INSULATION), AN UNINTENTIONAL ACTIVATION OF THE INSTRUMENT OR A HOT INSTRUMENT PLACED ON THE DRAPE, USE OF AN ALCOHOL-BASED DISINFECTANT THAT IGNITED WHEN DIATHERMY WAS APPLIED, ETC. THE GENERATOR PROBLEMS AND ERRORING DO NOT APPEAR TO BE DIRECTLY RELATED TO THE REPORTED INCIDENT (I.E., THE BURN TO THE PATIENT), BUT THE UNIT'S CONDITION CANNOT BE RULED OUT AS BEING FACTOR. FINALLY, BASED UPON THE PROVIDED INFORMATION, NO CONCLUSIVE DETERMINATION CAN BE MADE AS TO WHAT CAUSED THE PATIENT BURN. NO TRENDS HAVE BEEN IDENTIFIED AND ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT INCIDENT OCCURRED WITH THE ELECTROSURGICAL UNIT (ESU/GENERATOR) DURING AN IMPLANTATION OF A KNEE PROSTHESIS ON THE LEFT LEG. THE ESU WAS USED WITH A MEDIMEX MONOPOLAR HANDPIECE [PART NUMBER (P/N) 8M900046, LOT NUMBER (L/N) NOT PROVIDED]. A NEUTRAL ELECTRODE (NE) FROM THE COMPANY ASMUTH (P/N ASNE02, L/N NOT PROVIDED) WAS ATTACHED TO THE RIGHT THIGH. THE SETTINGS OF THE GENERATOR WERE CUT 150/EFFECT 3, COAG 60 FORCED. ACCORDING TO THE USER, THE ESU RELEASED ENERGY ON ITS OWN AND DISPLAYED AN ERROR MESSAGE BUT AN ACTIVATION TONE WAS NOT HEARD. A 1 CM X 1 CM HOLE WAS FOUND ON THE DRAPE. THE PATIENT HAD A 4 CM X 6 CM REDDENING, BLISTERING, NECROSIS (2ND TO 3RD DEGREE BURN) ON A LOWER LEG. THE WOUND WAS TREATED, BUT DETAILS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523424 ERBOTOM ICC 350 ELECTROSURGLCAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH ICC 350

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention