BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE

    MDR report key: 1689477 · Received May 10, 2010

    Report

    Report Number
    1820334-2010-00210
    Event Type
    Malfunction
    Date Received
    May 10, 2010
    Date of Event
    April 28, 2008
    Report Date
    April 13, 2010
    Manufacturer
    COOK INC
    Product Code
    DWO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT WEIGHT: UNKNOWN AS NOT PROVIDED BY REPORTER. EXPIRATION - UNKNOWN AS LOT IS UNKNOWN. APPROXIMATE AGE OF DEVICE: UNKNOWN AS LOT IS UNKNOWN. (B)(4): IT IS UNKNOWN IF THE DEVICE REMAINS IN THE PATIENT AS THIS INFORMATION WAS NOT PROVIDED BY REPORTER; TIP BREAKAGE IS NOT LISTED IN THE IFU. MANUFACTURE DATE: UNKNOWN AS LOT IS UNKNOWN. THE FOLLOWING HOOK WIRE CHARACTERISTICS ARE 100% INSPECTED FOR: LENGTH, SMOOTH DEPLOYMENT, ANGLE, AND APPEARANCE. EACH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) THAT WARNS "UNDER NO CIRCUMSTANCES SHOULD A HOOK WIRE ENGAGED IN TISSUE BE PULLED OUT WITHOUT SPECIAL 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." WITHOUT THE COMPLAINT DEVICE IT WILL NOT BE POSSIBLE TO MAKE AN INFORMED JUDGEMENT AS TO THE CAUSE OF THE SEPARATION. OTHER THAN NOTING THE IFU CAUTION STATEMENTS. WHETHER THIS SCENARIO CONTRIBUTED TO THE COMPLAINT IS UNKNOWN AT THIS TIME. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    ON (B)(6) 2008, A BIOPSY WAS PERFORMED ON A (B)(6), FEMALE, USING COOK KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE. THE RADIOLOGIST DID AN X-RAY FOR THE PLACEMENT OF THE NEEDLE, THE SURGEON WENT IN TO REMOVE THE MASS AND THE NEEDLE. APPROXIMATELY A YEAR AND A HALF LATER, THE PATIENT WENT IN FOR A MAMMOGRAM AND A PORTION OF THE WIRE WAS NOTED TO BE REMAINING IN THE BREAST. THE PHYSICIAN OBSERVED THE X-RAY AND IT APPEARS TO BE THE HOOK FROM THE WIRE. THE PATIENT APPEARED TO BE OK AFTER THE PROCEDURE. ACCORDING TO THE OFFICE MANAGER, SHE WAS DOING FINE AND HER FINAL VISIT WAS ON (B)(6) 2008. IT IS NOT KNOWN AT THIS TIME IF THE WIRE HAS BEEN REMOVED FROM THE PATIENT.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR