BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR CURVED CUTTER STAPLER CS

    MDR report key: 726471 · Received June 13, 2006

    Report

    Report Number
    1527736-2006-02700
    Event Type
    Malfunction
    Date Received
    June 13, 2006
    Date of Event
    May 19, 2006
    Report Date
    May 22, 2006
    Manufacturer
    ETHICON ENDO SURGERY, INC.(CINCINNATI)
    Product Code
    GDW
    PMA / PMN Number
    k040038
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H4: INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. 510(K) NUMBER IS K040038.

    Description of Event or Problem · 1

    THAT DURING AN LAR PROCEDURE, UPON FIRING THE CONCAVE SIDE OF THE RELOAD, NO STAPLES CAME OUT. THIS WAS ON THE FIRST FIRING. IT STAPLED ON ONE SIDE BUT NOT THE OTHER. CASE COMPLETED WITH ANOTHER STAPLER OF SAME PRODUCT CODE. NO PT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR CURVED CUTTER STAPLER CS GDW GDW ETHICON ENDO SURGERY, INC.(CINCINNATI) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN