BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MST8 FINAL ASSY JRZ

    MDR report key: 932891 · Received October 24, 2007

    Report

    Report Number
    1527736-2007-06984
    Event Type
    Malfunction
    Date Received
    October 24, 2007
    Date of Event
    September 18, 2007
    Report Date
    October 15, 2007
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    KNW
    PMA / PMN Number
    K003297
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 10/24/2007. INFO NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BREAST BIOPSY, THAT IT WAS IMPOSSIBLE TO OBTAIN SAMPLE. ANOTHER LIKE DEVICE WAS USED. THERE WAS NO ADVERSE PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MST8 FINAL ASSY JRZ KNW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4H68Z

    Patients

    Seq Age Sex Outcome Treatment
    1 YR CONTROL MODULE| HOLSTER