BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATOME STEREOTACTIC 11 G PROBE

    MDR report key: 1810062 · Received November 12, 2007

    Report

    Report Number
    1527736-2007-07507
    Event Type
    Malfunction
    Date Received
    November 12, 2007
    Date of Event
    October 18, 2007
    Report Date
    October 23, 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
    JA
    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 PROCEDURE, THE DEVICE COULD NOT PICK UP THE SAMPLE AND AFTER CHANGING TO A NEW DEVICE, IT DID PICK UP. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATOME STEREOTACTIC 11 G PROBE KNW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4H528

    Patients

    Seq Age Sex Outcome Treatment
    1 HOLSTER| CONTROL MODULE