BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE

    MDR report key: 7097457 · Received December 7, 2017

    Report

    Report Number
    1820334-2017-04152
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    October 17, 2017
    Report Date
    February 19, 2018
    Manufacturer
    COOK INC
    Product Code
    MIJ
    UDI-DI
    00827002028500
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND SPECIFICATIONS OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, 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 SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE KOPANS BREAST LOCALIZATION NEEDLE IS INTENDED FOR PREOPERATIVE MARKING OF NONPALPABLE BREAST LESIONS. BASED ON A DISCUSSION WITH THE RADIOLOGIST AND THE SURGEON, IT WAS STATED THAT THE AREA DID NOT NEED TO BE LOCALIZED. IT IS POSSIBLE THAT THE CAUSE OF HOOKWIRE FRACTURE IS USER TECHNIQUE, INAPPROPRIATE MEDICAL PROCEDURE OR HUMAN ANATOMY RELATED. IT IS ALSO POSSIBLE THAT THE HOOKWIRE WAS SUBJECTED TO FORCES BEYOND ITS INTENDED USE. HOWEVER, WITHOUT VISUAL INSPECTION OF THE AFFECTED PRODUCT OR ADDITIONAL INFORMATION FROM THE CUSTOMER, WE ARE UNABLE TO DETERMINE WITH CERTAINTY WHAT LED TO THE FAILURE MODE. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED 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

    510K STATUS: PREAMENDMENT. (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 ATTEMPTS WERE MADE TO "LOCALISE A LESION" [SIC]; HOWEVER, FOLLOWING A DISCUSSION WITH THE RADIOLOGIST AND THE SURGEON IT WAS DECIDED THAT THE AREA DID NOT NEED TO BE LOCALIZED. THE WIRE OF A KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE REPORTEDLY BROKE IN THE PATIENT'S BREAST "AT THE SHORT HOOK TURN" [SIC]. THIS APPROXIMATELY 9 MM PORTION OF THE HOOK WIRE WAS LEFT IN THE BREAST OF THE PATIENT. THE REMAINING COMPLAINT PRODUCT IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, THE DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874905 KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE MIJ NEEDLE, TUMOR LOCALIZATION MIJ COOK INC N/A 00827002028500

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention