BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MST8 FINAL ASSY JRZ

    MDR report key: 1508636 · Received October 7, 2009

    Report

    Report Number
    3005075853-2009-05996
    Event Type
    Malfunction
    Date Received
    October 7, 2009
    Date of Event
    September 29, 2009
    Report Date
    September 29, 2009
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    KNW
    PMA / PMN Number
    K003297
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. DEVICE BATCH #; F9GP82, F9GR93, AND F9GR11.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT DURING THE BREAST BIOPSY PROCEDURE THAT INADEQUATE SAMPLES WERE BEING OBTAINED. SEVERAL DRY TAPS AND FLUSHES WERE PERFORMED, BUT THE RESULT WAS THE SAME. THE DOCTOR WAS REMOVING THE NEEDLE AND WOULD FIND THE SPECIMEN ON THE END OF THE PROBE. EVENTUALLY, ENOUGH TISSUE WAS OBTAINED AND THE BIOPSY WAS CONSIDERED COMPLETED. A SECOND DEVICE WAS NEVER USED. THE DEVICE WAS DISCARDED AND CANNOT BE RETURNED. PATIENT INFO WAS REQUESTED AND OBTAINED. THE PATIENT WAS REPORTED TO BE DOING FINE AND IS BEING DISCHARGED HOME WITHOUT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MST8 FINAL ASSY JRZ KNW ETHICON ENDO-SURGERY, LLC NA F4NU34

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR HOLSTER| CONTROL MODULE