BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE

    MDR report key: 6996304 · Received November 2, 2017

    Report

    Report Number
    1820334-2017-03791
    Event Type
    Injury
    Date Received
    November 2, 2017
    Date of Event
    October 18, 2017
    Report Date
    February 21, 2018
    Manufacturer
    COOK INC
    Product Code
    MIJ
    UDI-DI
    00827002025868
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: A REVIEW OF THE DIMENSIONAL VERIFICATION, COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, SPECIFICATIONS, AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE HOOK WIRE WAS SEPARATED INTO TWO PIECES. THE HOOK ITSELF IS NOT INTACT ON EITHER PIECE. THE FIRST PIECE WAS BENT 90 DEGREES APPROXIMATELY 6.5 CM FROM THE SEPARATION. THE SECOND PIECE WAS BENT IN SEVERAL LOCATIONS. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    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, DURING PLACEMENT OF THE HOOK WIRE PORTION OF THE KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE, PART OF THE EXTERNAL WIRE REPORTEDLY SNAPPED OFF IN THE RADIOLOGIST'S HANDS AS THE DEVICE WAS BEING SECURED TO THE PATIENT'S CHEST WITH A DRESSING. TO SECURE THE DEVICE, IT IS REPORTEDLY COMMON PRACTICE TO BEND THE EXTERNAL WIRE A LITTLE. THE PATIENT UNDERWENT A SCHEDULED PROCEDURE ON THE SAME DAY, DURING WHICH THE PATIENT'S LUMP WAS RESECTED AND THE COMPLAINT PRODUCT WAS TO BE RETRIEVED; IT WAS THEN DISCOVERED DURING THIS PROCEDURE THAT THE A SECTION OF WIRE HAD ALSO FRACTURED JUST UNDER THE PATIENT'S SKIN AS WELL. THE OPERATOR REMOVED BOTH THE HOOK WIRE AND THE DISCOVERED WIRE FRAGMENT FROM THE PATIENT. ALL FRAGMENTS OF THE WIRE WERE ULTIMATELY RECOVERED. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775164 KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE MIJ NEEDLE, TUMOR LOCALIZATION MIJ COOK INC N/A 00827002025868

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention