BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MST8 FINAL ASSY JRZ

    MDR report key: 1830332 · Received October 26, 2007

    Report

    Report Number
    1527736-2007-07060
    Event Type
    Malfunction
    Date Received
    October 26, 2007
    Date of Event
    October 2, 2007
    Report Date
    October 2, 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). INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BREAST BIOPSY, AFTER THE INITIAL SPECIMEN CUT, THE PROBE FAILED TO RETRIEVE ADD'L SPECIMENS. USED ANOTHER LIKE DEVICE TO FINISH THE BIOPSY. THERE WERE NO PATIENT CONSEQUENCES.

    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 CONTROL MODULE| HOLSTER