BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1G BLADED MAMMOTOME ST PROBE

    MDR report key: 1823676 · Received November 16, 2007

    Report

    Report Number
    1527736-2007-07791
    Event Type
    Malfunction
    Date Received
    November 16, 2007
    Date of Event
    October 23, 2007
    Report Date
    October 31, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    KNW
    PMA / PMN Number
    K991980
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 DURING BREAST BIOPSY PROCEDURE ADEQUATE SAMPLES WERE NOT OBTAINED. THE PROBE WAS REPLACED AND THE CASE WAS COMPLETED WITH NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1G BLADED MAMMOTOME ST PROBE KNW ETHICON ENDO SURGERY, INC. (CINCINNATI) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 HOLSTER| CONTROL MODULE