BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE

    MDR report key: 5842796 · Received August 3, 2016

    Report

    Report Number
    1820334-2016-00700
    Event Type
    Injury
    Date Received
    August 3, 2016
    Date of Event
    June 16, 2016
    Report Date
    July 7, 2016
    Manufacturer
    COOK INC
    Product Code
    MIJ
    UDI-DI
    00827002035072
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DEVICE PRODUCT CODE: MIJ NEEDLE, TUMOR LOCALIZATION. INVESTIGATION RESULTS- A REVIEW OF COMPLAINT HISTORY, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL MEASURES, SPECIFICATIONS AND A REVIEW OF TRENDS WAS CONDUCTED TO ASSIST IN THE INVESTIGATION. THE DEVICE WILL NOT BE RETURNED TO AID IN THE INVESTIGATION OF THE ALLEGED PRODUCT FAILURE. SINCE THE DEVICE WAS NOT RETURNED, EXAMINATION COULD NOT BE PERFORMED. COMPLAINT WILL BE CONFIRMED BASED ON CUSTOMERS TESTIMONY. THIS IS THE ONLY COMPLAINT FOR THIS FAILURE FROM 01JAN2013 TO 19OCT2016 FOR THIS DEVICE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO NON-CONFORMANCES WERE NOTED. THERE IS NO EVIDENCE TO SUGGEST THAT DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER RISK ASSESSMENT NO FURTHER ACTIONS ARE NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    PER (B)(4), REPORTED THROUGH THE FDA VOLUNTARY EVENT REPORTING PROCESS, THE MANUFACTURER WAS INFORMED THAT DURING A WIRE LOCALIZED PARTIAL MASTECTOMY ON A (B)(6) FEMALE PATIENT, THE TIP OF A BREAST LESION LOCALIZATION WIRE BROKE INSIDE THE PATIENT'S BREAST. THE PROVIDER WAS UNABLE TO LOCATE AND RETRIEVE THE TIP WHEN PERFORMING SURGERY. THIS WAS DISCLOSED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494948 KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE MIJ NEEDLE, TUMOR LOCALIZATION MIJ COOK INC N/A 00827002035072

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other| R