BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8G MAMMOMARK BREAST MARKER

    MDR report key: 1820994 · Received October 9, 2007

    Report

    Report Number
    1527736-2007-06677
    Event Type
    Malfunction
    Date Received
    October 9, 2007
    Date of Event
    September 4, 2007
    Report Date
    September 19, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    FZP
    PMA / PMN Number
    K003777
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE TIP OF THE APPLIER TUBE BROKE OFF INSIDE OF THE PROBE. FINISHED THE BIOPSY USING ANOTHER DEVICE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8G MAMMOMARK BREAST MARKER FZP ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4HC6Y

    Patients

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