BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CABLE

    MDR report key: 7523034 · Received May 17, 2018

    Report

    Report Number
    3000719969-2018-00006
    Event Type
    Malfunction
    Date Received
    May 17, 2018
    Date of Event
    April 20, 2018
    Report Date
    May 17, 2018
    Manufacturer
    OLSEN MEDICAL LLC
    Product Code
    GEI
    PMA / PMN Number
    K111262
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CORD WAS SOLD PRIOR TO 9/9/2016. THE IFU FOR THIS CORDS STATES THAT IT IS "DESIGNED TO WITHSTAND A MINIMUM OF 20 STERILIZATION CYCLES" WHEN PROPERLY CARED FOR. THE CORD SHOWS SIGNIFICANT SIGNS OF USE AND WAS SOLD MORE THAN 1.5 YEARS AGO. THE CORD WAS USED BEYOND ITS USEFUL LIFE.

    Description of Event or Problem · 1

    A BIPOLAR CORD CAUSED A FIRE IN THE OPERATING ROOM (OR), IT CAME APART WHERE IT WAS CONNECTED TO THE SPATULA DURING A LAVH WITH DACOSTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367057 MONOPOLAR CABLE MONOPOLAR CABLE GEI OLSEN MEDICAL LLC 60-5169-001

    Patients

    Seq Age Sex Outcome Treatment
    1