BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE

    MDR report key: 1513352 · Received October 13, 2009

    Report

    Report Number
    1820334-2009-00587
    Event Type
    Malfunction
    Date Received
    October 13, 2009
    Report Date
    September 18, 2009
    Manufacturer
    COOK, INC.
    Product Code
    DWO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS UNK AS NOT PROVIDED BY REPORTER. (B)(4). THE FOLLOWING HOOK WIRE CHARACTERISTICS ARE 100% INSPECTED FOR: LENGTH, SMOOTH DEPLOYMENT, ANGLE, AND APPEARANCE PRIOR TO SHIPPING. THE DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) THAT WARNS "UNDER NO CIRCUMSTANCES SHOULD A HOOK WIRE ENGAGED IN TISSUE BE PULLED OUT WITHOUT SURGICAL INTERVENTION." THE IFU ALSO CAUTIONS THAT "FOLLOWING PLACEMENT OF THE HOOKWIRE, THE PORTION PROTRUDING OUTSIDE OF THE BREAST SHOULD BE BENT AND TAPED TO THE SKIN TO PREVENT INADVERTENT MOVEMENT." THE IFU ALSO ADDS "THE HOOK WIRE SHOULD BE USED AS A GUIDE FOR THE SURGEON, NOT A RETRACTOR." AT THE TIME OF THE INVESTIGATION, THE CUSTOMER HAD NOT RETURNED THE COMPLAINT DEVICE, NOR PROVIDED THE LOT NUMBER. IT WAS REPORTED THAT THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE EVENT. HOWEVER, THE CUSTOMER DID NOT PROVIDE A DESCRIPTION OF ACTIONS THAT WERE TAKEN AS A RESULT OF THE EVENT. IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE EVENT WITHOUT THE COMPLAINT DEVICE AND ADDITIONAL INFORMATION; ALTHOUGH, IT IS POSSIBLE THAT THE DEVICE MET RESISTANCE BEYOND ITS INTENDED DESIGN RESULTING IN SEPARATION. SEPARATION OF THE WIRE WOULD RESULT IN THE NEED FOR MEDICAL OR SURGICAL INTERVENTION. WE WILL NOTIFY THE APPROPRIATE PERSONNEL OF THE EVENT AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    PLACED THE NEEDLE FOR BREAST LESION LOCALIZATION. CAUTERIZING THE BREAST - IN DOING SO, THE WIRE IS BREAKING/SHATTERING IN THE PATIENT. THEY ARE AWARE OF TWO OTHER INCIDENTS, BUT NO DETAILS ARE AVAILABLE AT THIS TIME. NO HARM TO THE PATIENT WAS REPORTED.

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN