BEUDAMED
    FDA Adverse Event Other Summary report: N

    MONOPOLAR CORD

    MDR report key: 1730111 · Received June 18, 2010

    Report

    Report Number
    1530493-2010-00003
    Event Type
    Other
    Date Received
    June 18, 2010
    Date of Event
    May 11, 2010
    Report Date
    June 17, 2010
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    K971540
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY OLSEN MEDICAL. THE CORD HAD EVIDENCE OF IMPROPER REMOVAL FROM THE ESU BY REMOVING IT WITH THE CORD, NOT THE FLANGE. THIS IS ATTRIBUTED TO USE ERROR.

    Description of Event or Problem · 1

    THE ACTUAL DATE OF EVENT IS UNK, BUT WAS APPROXIMATELY AROUND (B)(6) 2010. DURING LAP CHOLE PROCEDURE THE LIGHTS WERE OUT IN THE OPERATING ROOM AND A COMPETITOR REPRESENTATIVE NOTICED A RED GLOW ON THE DEVICE WHERE THE CORD MET THE MOLDED PLASTIC PLUG AND THE DEVICE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CORD REUSABLE MONOPOLAR CORD GEI OLSEN MEDICAL 90056 014589

    Patients

    Seq Age Sex Outcome Treatment
    1 Other