BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE

    MDR report key: 2572748 · Received May 3, 2012

    Report

    Report Number
    1820334-2012-00237
    Event Type
    Injury
    Date Received
    May 3, 2012
    Date of Event
    March 19, 2012
    Report Date
    April 13, 2012
    Manufacturer
    COOK, INC.
    Product Code
    DWO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): REMOVAL OF FOREIGN BODY IS NOT LISTED IN THE INSTRUCTIONS FOR USE. SEPARATES IS NOT LISTED IN THE INSTRUCTIONS FOR USE. EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    DURING SURGERY, THE PHYSICIAN HELD THE WIRE UP TO MAKE THE INCISION AND THE WIRE CAME OUT. A REVIEW NOTED THE HOOK WAS NO LONGER PRESENT; THE HOOK WAS STILL IN THE BREAST TISSUE. THE TISSUE SAMPLE WAS REMOVED AND THE PHYSICIAN WAS ABLE TO REMOVE THE HOOK FROM THE PT; EVERYTHING WAS REMOVED FROM THE PT. THERE WAS NO HARM TO THE PT REPORTED. THE LOCALIZATION IS INSERTED PRIOR TO SURGERY AND EVERYTHING REMOVED DURING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE DWO NEEDLE, BIOPSY, CARDIOVASCULAR DWO COOK, INC. NA 2809311

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention