BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE KOPANS SPRING HOOK LOCALIZATION NEEDLE

    MDR report key: 1023284 · Received April 1, 2008

    Report

    Report Number
    1820334-2008-00158
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    February 20, 2008
    Report Date
    March 3, 2008
    Manufacturer
    COOK INCORORATED
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: NO PRODUCT WAS RETURNED TO ASSIST IN THIS INVESTIGATION. INSPECTION CHECKS ARE PERFORMED PRIOR TO SHIPPING TO ENSURE THAT THE HOOKWIRE DEPLOYS SMOOTHLY AND VERIFIES SMOOTHER AND SECURE SOLDER JOINT AT BOTH ENDS OF THE CANNULA AS WELL AS THE "LOOP" AT THE DISTAL END OF THE HOOKWIRE IS A LOOP. THE DEVICE IS ALSO CHECKED TO ENSURE THAT IT IS NOT KINKED AND THAT IT IS THE CORRECT DIAMETER. COOK'S CAUTION LABEL DOES INDICATE THAT THE HOOKWIRE SHOULD BE USED AS A GUIDE FOR THE SURGEON, NOT A RETRACTOR.

    Description of Event or Problem · 1

    DURING A BREAST LOCALIZATION, THE WIRE BROKE OFF AND REMAINS IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE KOPANS SPRING HOOK LOCALIZATION NEEDLE FMI NEEDLE FMI COOK INCORORATED NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other