BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11G BLADED MAMMOTOME ST PROBE

    MDR report key: 1831399 · Received December 17, 2007

    Report

    Report Number
    1527736-2007-08519
    Event Type
    Malfunction
    Date Received
    December 17, 2007
    Date of Event
    November 29, 2007
    Report Date
    November 29, 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
    MA, 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, THE FIFTH SAMPLING DID NOT RETURN ANY SAMPLES. TRIED TAKING ADDITIONAL SAMPLES AT DIFFERENT CLOCK POSITIONS, CLEARING THE PROBE WITH CLEAR PROBE MODE, CLEANING OUT THE KNOCKOUT PIN, AND FLUSHING THE PROBE AND TUBING WITH LIDOCAINE AND STILL DIDN'T RETRIEVE ANY SAMPLES. THE DOCTOR DECIDED TO REMOVE THE PROBE AND TRY A SECOND PROBE. THE SECOND PROBE INITIALIZED AND WAS PLACED BACK INTO THE BREAST BUT THE DOCTOR WASN'T ABLE TO FIND ANY CALCIFICATIONS UNDER X-RAY AND DECIDED TO STOP THE CASE AT THAT POINT, HAVING OBTAINED FOUR GOOD SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 11G BLADED MAMMOTOME ST PROBE KNW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 HOLSTER| CONTROL MODULE