BEUDAMED
    FDA Adverse Event Other Summary report: N

    ERBOTOM ICC 300

    MDR report key: 922584 · Received October 1, 2007

    Report

    Report Number
    9610614-2007-00024
    Event Type
    Other
    Date Received
    October 1, 2007
    Report Date
    October 1, 2007
    Manufacturer
    ERBE ELECTROMEDIZIN GMBH
    Product Code
    GEI
    PMA / PMN Number
    K953738
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT INVOLVED THE POLICE. THEREFORE, THE AUTHORITIES INITIALLY CONFISCATED THE GENERATOR AND INVOLVED ACCESSORIES. BUT THE EQUIPMENT HAS SINCE BEEN RELEASED AND IS BEING EVALUATED. IF ANY EQUIPMENT PROBLEM IS FOUND THAT COULD BE ASSOCIATED WITH THE EVENT, THEN IT WILL BE DETAILED IN A FOLLOW UP REPORT. NONETHELESS, IT APPEARS THAT THE CLINICIANS WERE DIRECTLY RESPONSIBLE FOR THE INCIDENT. MOST LIKELY, A COMBUSTIBLE DISINFECTANT OR AN OXYGEN SOURCE WAS IGNITED DUE TO THE CAUTERY DEVICE BEING PLACED IN ITS VICINITY (I.E. LAID ON THE PATIENT'S NECK). WARNINGS IN THE ESU'S USER MANUAL CAUTION MEDICAL PERSONNEL NOT TO LAY INSTRUMENTS ON PATIENTS, TO BE AWARE OF COMBUSTIBLE SITUATIONS, ETC. FINALLY, NO ANOMALIES WERE FOUND IN THE DEVICE HISTORY RECORD (DHR). NO TRENDS HAVE BEEN IDENTIFIED WITH THIS INCIDENT. ERBE USA, INC. IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTROSURGICAL UNIT (ESU/GENERATOR) WAS INVOLVED IN A PATIENT INCIDENT. THE ESU WITH A BIPOLAR FORCEP WAS USED IN SURGERY ON EYELIDS. THE INSTRUMENT WAS LAID DOWN ON THE PATIENT'S THORAX WHICH RESULTED IN FLAMES APPEARING ON THE PATIENT'S NECK. THE SURGICAL FIELD WAS BURNT AND THE PATIENT SUFFERED 2ND DEGREE BURNS ON THE NAPE OF THE NECK. NO FURTHER INFORMATION ON THE PATIENT OR ANY ADDITIONAL MEDICAL TREATMENT WAS PROVIDED. THE UNIT WAS DISTRIBUTED BY OUR PARENT COMPANY TO A HOSPITAL IN ANOTHER COUNTRY. THEREFORE, THE PART (CATALOGUE) NUMBER OF THE GENERATOR IS DIFFERENT THAN THE NUMBER IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ERBOTOM ICC 300 ELECTROSURGICAL GENERATOR GEI ERBE ELECTROMEDIZIN GMBH ICC 300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR Other