BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MST8 FINAL ASSY JRZ

    MDR report key: 1314963 · Received February 19, 2009

    Report

    Report Number
    1527736-2008-02264
    Event Type
    Malfunction
    Date Received
    February 19, 2009
    Date of Event
    March 25, 2008
    Report Date
    March 25, 2008
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    KNW
    PMA / PMN Number
    K003297
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 04/16/2008. OTHER#= E9U1R (BATCH # FOR DEVICE B); EXP DATE = 02/2013 (DEVICE B). (DEVICE B): 3/2008. EVAL SUMMARY: DEVICE A, B AND C WERE RETURNED IN GOOD PHYSICAL CONDITION. THE PROBES WERE CONNECTED TO A TEST HOLSTER AND CONTROL MODULE, INITIALIZED, FIRED AND FUNCTIONED PROPERLY. THE CUTTING FEATURE OF THE INSTRUMENTS WAS EVALUATED WITH A TEST MEDIA AND ALL THREE CUT AS INTENDED. IN ADDITION, THE VACUUM FEATURES WERE FOUND TO BE FULLY FUNCTIONAL. THE PROBES WERE FULLY FUNCTIONAL AND CONFORMING TO MANUFACTURING REQUIREMENTS. NO ERROR CODES WERE NOTED DURING ANALYSIS. WHILE WE WERE UNABLE TO RE-CREATE THE EVENT, WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. A BATCH RECORD REVIEW WAS DETERMINED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BREAST BIOPSY, THE FIRST PROBE WOULDN'T INITIALIZE. A SECOND AND THIRD PROBE TOOK ONE SAMPLE AND DIDN'T GET ANY ADDITIONAL SAMPLES AFTERWARD. THE NEEDED SAMPLES WERE OBTAINED WITH A FOURTH PROBE AND THE CASE WAS COMPLETED WITH NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MST8 FINAL ASSY JRZ KNW KNW ETHICON ENDO SURGERY, INC. (CINCINNATI) NA C4F54E

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTROL MODULE| HOLSTER