BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATOME STEREOTACTIC 11 G PROBE

    MDR report key: 1822277 · Received December 6, 2007

    Report

    Report Number
    1527736-2007-08333
    Event Type
    Malfunction
    Date Received
    December 6, 2007
    Date of Event
    November 26, 2007
    Report Date
    November 26, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BREAST BIOPSY, WHILE TRYING TO TAKE A SAMPLE, KEPT RECEIVING ERROR CODES. THE CASE WAS ABORTED. THE PT WILL BE RESCHEDULED ONCE LOANERS CAN BE ATTAINED. NO PT CONSEQUENCE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATOME STEREOTACTIC 11 G PROBE KNW ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA D4JN1R

    Patients

    Seq Age Sex Outcome Treatment
    1 HOLSTER| CONTROL MODULE