BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CABLE W/4MM LAP CONNECTION

    MDR report key: 3015089 · Received February 20, 2013

    Report

    Report Number
    1530493-2013-00001
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    November 5, 2012
    Report Date
    February 20, 2013
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    K111262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING A HERNIA REPAIR, A MONOPOLAR CABLE MELTED ON THE GENERATOR END WHERE THE PLUG MEETS THE CABLE. ONCE IT SHORTED, IT CAUGHT FIRE. THERE WAS NO INJURY TO THE PATIENT AND AFTER THE EVENT, THE SURGERY WAS COMPLETED AS PLANNED. NO ONE IN THE OPERATING ROOM WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74634 MONOPOLAR CABLE W/4MM LAP CONNECTION GEI OLSEN MEDICAL 90091 018276

    Patients

    Seq Age Sex Outcome Treatment
    1