BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MST8 FINAL ASSY JRZ

    MDR report key: 1316963 · Received February 20, 2009

    Report

    Report Number
    1527736-2008-02178
    Event Type
    Malfunction
    Date Received
    February 20, 2009
    Date of Event
    March 19, 2008
    Report Date
    March 19, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC.
    Product Code
    KNW
    PMA / PMN Number
    K003297
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER, THE DR WAS PERFORMING A BREAST BIOPSY AND EACH OF SIX PROBES, TWO 11 GA AND FOUR 8 GA, WOULD RETRIEVE A SAMPLE, BUT WOULDN'T RETRIEVE ANY ADD'L SAMPLES. TO ATTAIN THE NEEDED SAMPLES, THE DR WOULD TRANSITION THE CUTTER FORWARD TO TAKE THE SAMPLE, MANUALLY REMOVE THE PROBE FROM THE BREAST, REMOVE THE SAMPLE FROM THE SAMPLE CHAMBER, REINSERT THE PROBE INTO THE BREAST AND CONTINUE SAMPLING. THE CUSTOMER NOTICED THERE WASN'T ANY VACUUM COMING BACK TO THE AXIAL END OF THE PROBE. THE CASE WAS COMPLETED WITH NO PT CONSEQUENCE. ONE OF THE PROBES IS AVAILABLE TO BE RETURNED FOR ANALYSIS BY THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1