BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FZP CLIP, IMPLANTABLE

    MDR report key: 1373512 · Received May 4, 2009

    Report

    Report Number
    3005075853-2009-02678
    Event Type
    Injury
    Date Received
    May 4, 2009
    Date of Event
    April 1, 2009
    Report Date
    April 10, 2009
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    FZP
    PMA / PMN Number
    K003777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 5/4/2009. INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BREAST BIOPSY, WHEN ATTEMPTING TO DEPLOY THE MARKER, ENCOUNTERED SOME RESISTANCE BUT MANAGED TO PUSH THE MARKER FORWARD TO DEPLOY INTO THE BREAST. THEY WAITED A FEW MINUTES, PULLED THE COMPLETE SET OUT OF THE BREAST AND NOTICED THE MARKER AND PART OF THE APPLICATOR HAD SHEARED OFF IN THE BREAST. THE DOCTOR REMOVED THE PT FROM THE TABLE, MADE A THREE AND ONE HALF INCISION IN THE BREAST AND EXCISED THE MARKER AND SHEARED APPLICATOR OUT OF THE BREAST. THE INCISION WAS CLOSED WITH SUTURES AND THE PT WENT HOME THE SAME DAY. ACCORDING TO THE CUSTOMER, THE PT IS HEALING FINE. ALL PARTS OF THE DEVICE WERE DISPOSED OF. NO OTHER MARKER WAS DEPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FZP CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC NA D4GX08

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTROL MODULE| HOLSTER| PROBE