BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MST8 FINAL ASSY JRZ

    MDR report key: 1830293 · Received October 26, 2007

    Report

    Report Number
    1527736-2007-07079
    Event Type
    Malfunction
    Date Received
    October 26, 2007
    Date of Event
    September 26, 2007
    Report Date
    October 8, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: NO CONCLUSION COULD BE REACHED BASED ON THE ANALYSIS RESULTS AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE MST8 DEVICE WAS RETURNED IN GOOD PHYSICAL CONDITION. THE PROBE WAS CONNECTED TO A TEST HOLSTER AND CONTROL MODULE, INITIALIZED, AND WORKED PROPERLY DURING ANALYSIS. THE INSTRUMENT WAS TESTED WITH A TEST TUBING SET AND NO ANOMALIES WERE NOTED ON THE VACUUM FUNCTIONALITY OF THE INSTRUMENT. THE INSTRUMENT WAS TESTED WITH A TEST MEDIA AND NO ANOMALIES WERE NOTED ON THE CUTTING FUNCTIONALITY OF THE DEVICE. THE PROBE WAS FULLY FUNCTIONAL AND CONFORMING TO MFG REQUIREMENTS. 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. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED BY THE CUSTOMER THE PROBE HAD TAKEN TWO SAMPLES AND DIDN'T RETURN ANY SAMPLES ON THE THIRD TRY. THE VACUUM WAS INCREASED AND THE KNOCKOUT TUBE WAS CLEARED BUT NO SAMPLES COULD BE RETURNED. THE PROBE WAS SWAPPED WITH ANOTHER PROBE AND THE CASE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. ONE DEVICE 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 ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4J18V

    Patients

    Seq Age Sex Outcome Treatment
    1