BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLMAN

    MDR report key: 2975454 · Received February 7, 2013

    Report

    Report Number
    2428235-2013-00001
    Event Type
    Malfunction
    Date Received
    February 7, 2013
    Date of Event
    January 9, 2013
    Report Date
    February 4, 2013
    Manufacturer
    ELLMAN INT'L INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIPOLAR ADAPTOR CABLE AND GENERATOR INVOLVED IN THE INCIDENT WERE INSPECTED. THE GENERATOR WAS FUNCTIONING NORMALLY. IT WAS NOTED UPON INSPECTION THAT THE OUTER INSULATION ON THE BIPOLAR ADAPTOR CABLE WAS DAMAGED (CUT). IT IS SURMISED THAT THE CUT BIPOLAR ADAPTOR CABLE CAUSED THE ISSUE. THE BIPOLAR ADAPTOR CABLE IS REUSABLE AND SHOULD BE INSPECTED FOR DAMAGE PRIOR TO EACH USE AS INDICATED IN THE USER MANUAL. THE BIPOLAR ADAPTOR CABLE DAMAGE INDICATES INSPECTION WAS NOT PERFORMED.

    Description of Event or Problem · 1

    THE ELLMAN SURGITRON WAS BEING USED ON A (B)(6) FEMALE PATIENT UNDERGOING A LAPAROSCOPIC MYOMECTOMY WHEN THE BIPOLAR ADAPTOR CABLE IGNITED IN FLAMES. WHEN THE GENERATOR WAS TURNED OFF, THE FLAMES FROM THE BIPOLAR ADAPTOR CABLE SELF-EXTINGUISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53241 ELLMAN BIPOLAR ADAPTOR CABLE GEI ELLMAN INT'L INC. IEC-BIUC

    Patients

    Seq Age Sex Outcome Treatment
    1