BEUDAMED
    FDA Adverse Event Other Summary report: N

    DISPOSABLE KOPANS SPRING HOOK LOCALIZER NEEDLE

    MDR report key: 495742 · Received November 12, 2003

    Report

    Report Number
    1820334-2003-00222
    Event Type
    Other
    Date Received
    November 12, 2003
    Date of Event
    October 3, 2003
    Report Date
    October 16, 2003
    Manufacturer
    COOK, INC.
    Product Code
    GDF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS BEING UTILIZED DURING A BILATERAL NEEDLE LOCALIZATION. THE SURGEON WAS CAUTERIZING CLOSE TO THE HOOK WIRE, BUT NOT TOUCHING IT AND THE HOOK WIRE MELTED INTO TWO PIECES. THERE WAS NO INJURY TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE KOPANS SPRING HOOK LOCALIZER NEEDLE NEEDLE GDF COOK, INC. NA F1458057

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other