BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE

    MDR report key: 7107559 · Received December 12, 2017

    Report

    Report Number
    1820334-2017-04361
    Event Type
    Injury
    Date Received
    December 12, 2017
    Report Date
    March 7, 2018
    Manufacturer
    COOK INC
    Product Code
    MIJ
    UDI-DI
    00827002025875
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND TRENDS OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE PRODUCT WAS SCRAPPED AFTER USE AND COULD NOT BE RETURNED. THUS, A DEVICE FAILURE ANALYSIS COULD NOT BE COMPLETED. SIMILAR RELATED COMPLAINTS (B)(4) WERE REFERENCED IN LIEU OF THE UNRETURNED DEVICE, REVEALING THE NEEDLES ARE TOO EASILY DISPLACED/DISLODGED ( TRENDED AS ¿CUSTOMER DISSATISFACTION"). THE DEVICE HISTORY RECORD FOR THE DKBL-20-9.0-A KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE AND ALL OF ITS SUBASSEMBLY COMPONENTS WERE REVIEWED, INCLUDING THE BBL-10-25.0-DKBL-A HOOKWIRE. THESE WORK ORDERS INDICATED NON-CONFORMANCES WERE PRESENT, HOWEVER, ALL NON-CONFORMANCES WERE PROPERLY REWORKED OR SCRAPPED BEFORE THE LOT WAS RELEASED AND DETERMINED TO NOT HAVE CONTRIBUTED TO THE REPORTED FAILURE. A REVIEW OF THE DEVICE MASTER RECORD WAS REVIEWED, VERIFYING THE PROPER DOCUMENTS ARE IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. BASED ON THE INFORMATION ABOVE, THERE IS NO EVIDENCE TO SUGGEST THIS FAILURE WAS MANUFACTURING RELATED. A SEARCH FOR SIMILAR COMPLAINTS ON OUR COMPLAINT MANAGEMENT SYSTEM REVEALED ONE OTHER COMPLAINT ASSOCIATED WITH THE LOT NUMBER 7202056. THE ADDITIONAL COMPLAINT ON THIS LOT (B)(4) WIRE DID NOT ENGAGE AS IT SHOULD) IS RELATED TO THIS REPORTED COMPLAINT (B)(4), AS THIS WAS THE SUBSEQUENT PROCEDURE TO COMPLETE THE LUMPECTOMY. THIS COMPLAINT WAS CONFIRMED SOLELY BY CUSTOMER TESTIMONY. BECAUSE THE HOOKWIRE MOVED FROM ITS DESIRED POSITION AFTER IT WAS PLACED INSIDE OF THE PATIENT, THIS COMPLAINT WILL BE TRENDED AS ¿MIGRATION¿. HOWEVER, IT CANNOT BE DETERMINED WHY OR HOW THE HOOKWIRE BECAME DISLODGED AND REMOVED FROM ITS DESIRED POSITION IN THE PATIENT. NO INFORMATION COULD BE PROVIDED REGARDING THE SECUREMENT OF THE HOOKWIRE AFTER IT WAS PLACED. IT IS REASONABLE TO SUGGEST THAT THE PORTION OF THE HOOKWIRE PROTRUDING OUTSIDE OF THE BREAST AFTER PLACEMENT WAS NOT PROPERLY TAPED TO THE BREAST, CAUSING THE DEVICE TO MOVE FROM ITS DESIRED POSITION. A DIFFICULT PATIENT ANATOMY COULD HAVE ALSO ATTRIBUTED TO THE FAILURE. ALTHOUGH THERE IS NO EVIDENCE TO SUGGEST THIS FAILURE IS MANUFACTURING RELATED, BECAUSE THE DEVICE WAS NOT RETURNED AND NO PHOTOS WERE PROVIDED, IT COULD NOT BE DETERMINED WHETHER THE REPORTED DEVICE WAS BUILT TO SPECIFICATION. FURTHERMORE, ANY OF THESE POSSIBILITIES CANNOT BE CONFIRMED, AND THIS ROOT CAUSE WILL BE LISTED AS, ¿INCONCLUSIVE¿. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE PROPER PERSONNEL ABOUT THIS EVENT. THERE IS NO EVIDENCE THAT NON-CONFORMING PRODUCT EXISTS IN THE FIELD. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THAT THE WIRE INCLUDED IN THE KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE SET HAD DISLODGED FROM THE PATIENT. THE DEVICE HAD BEEN PLACED PRIOR TO A SCHEDULED LUMPECTOMY, AND THE PRODUCT ISSUE WAS NOTICED ONCE THE PATIENT REACHED THE OPERATING ROOM. AT THIS POINT, THE PATIENT WAS RESCHEDULED FOR ANOTHER PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER, BUT NONE HAS YET BEEN PROVIDED. THE DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887827 KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE MIJ NEEDLE, TUMOR LOCALIZATION MIJ COOK INC N/A 00827002025875

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention