BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ERBE VIO 300 D

    MDR report key: 18845717 · Received March 6, 2024

    Report

    Report Number
    9610614-2024-00018
    Event Type
    Injury
    Date Received
    March 6, 2024
    Date of Event
    February 20, 2024
    Report Date
    March 6, 2024
    Manufacturer
    ERBE ELEKTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K083452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ESU WAS RETURNED AND THOROUGHLY INSPECTED/TESTED. A TECHNICAL SAFETY CHECK WAS PERFORMED ON THE UNIT. THIS INCLUDED AN ELECTRICAL SAFETY CHECK, A FUNCTION CHECK OF EACH OF THE EQUIPMENT'S FEATURES, AND A POWER OUTPUT CHECK. ALL FEATURES WERE/ARE FUNCTIONING PROPERLY WITHIN SPECIFICATIONS ON THE DEVICE. IN CONCLUSION, NO ERBE EQUIPMENT PROBLEM WAS FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE EVENT. BASED UPON THE PROVIDED INFORMATION, IT APPEARS THAT THE ACTIVATION OF ELECTROSURGICAL UNIT LED TO A FLAME AND THEN COMBUSTION/DEFLAGRATION IN THE PATIENT'S MOUTH AREA DUE TO THE PRESENCE OF OXYGEN, ANESTHETIC GAS, AND/OR DISINFECTANT AT A COMBUSTIBLE LEVEL. THE ESU'S USER MANUAL WARNS THAT COMBUSTION-PROMOTING GASES SUCH AS OXYGEN REPRESENT A FIRE HAZARD FOR PATIENTS AND STAFF AND THAT COMBUSTION-PROMOTING GASES MAY NOT BE USED DURING OPERATIONS IN THE HEAD/THORAX AREA OR THAT THEY MUST BE SUCTIONED OFF BEFORE USING ELECTROSURGERY. THE OXYGEN-CARRYING TUBES/ENDOTRACHEAL TUBES MUST THEREFORE ALSO BE CHECKED FOR LEAKS. THE MANUAL ALSO WARNS THAT THAT THERE IS A RISK OF EXPLOSION FOR THE PATIENT AND USER IF IGNITABLE ANESTHETICS ARE USED DURING OPERATIONS ON THE HEAD OR THORAX AND THE ANESTHETICS MUST BE ASPIRATED BEFORE USING ELECTROSURGERY. FINALLY, PER THE USER MANUAL, FLAMMABLE DISINFECTANTS CAN ALSO POSE A RISK OF FIRE AND EXPLOSION, AND THESE MUST HAVE COMPLETELY EVAPORATED AND/OR NOT ACCUMULATE IN RECESSES IN THE BODY BEFORE ELECTROSURGERY IS USED. 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 THE ELECTROSURGICAL UNIT (ESU/GENERATOR) WAS INVOLVED IN A PATIENT INCIDENT. THE ESU WAS USED AS PART OF AN EXCISION WITH CLOSURE OF A TRACHEAL FISTULA AFTER A TRACHEOSTOMY. AN ERBE MONOPOLAR CABLE [PART NUMBER (P/N) 20192-127, LOT NUMBER (L/N) INFOMATION NOT PROVIDED (NI)], AN ERBE ELECTRODE HANDLE WITH 2 BUTTONS (P/N 20190-045, L/N WO (B)(4)), AN ERBE KNIFE ELECTRODE (P/N 21191-000, L/N WO (B)(4)) AND AN ERBE NEUTRAL ELECTRODE CABLE (P/N 20194-077, L/N NI) WERE USED WITH THE GENERATOR (NOTE: IT WAS REPORTED THAT THE ERBE ACCESSORIES WERE FUNCTIONAL AND WITHOUT DEFECTS.). INFORMATION REGARDING ANY OTHER EQUIPMENT OR ACCESSORY USED IN THE PROCEDURE WAS NOT PROVIDED. ALSO, NO INFORMATION WAS PROVIDED INVOLVING THE GENERATOR'S SETTINGS (E.G., MODE, EFFECT, ETC.). DURING INTUBATION ANESTHESIA, THE FISTULA WAS CUT IN A SPINDLE-SHAPED MANNER AND COAGULATED WITH ELECTROSURGERY. THEN, SUDDENLY A DEFLAGRATION (I.E., COMBUSTION) OCCURRED WHICH CAUSED THE PATIENT'S ORAL CAVITY (I.E., MOUTH, THROAT, EPIGLOTTIS) TO BE BURNED. THE WOUND WAS IMMEDIATELY COOLED WITH WATER AND THE PATIENT WAS REINTUBATED (NOTE: THE REMOVED INTUBATION TUBE WAS BLACK.). NO ADDITIONAL INFORMATION WAS CONVEYED TO ERBE REGARDING THE PATIENT'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1538838 ERBE VIO 300 D ELECTROSURGICAL UNIT GEI ERBE ELEKTROMEDIZIN GMBH VIO 300 D

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention