BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA ROTICULATOR 60-3.5 SULU

    MDR report key: 2042270 · Received March 29, 2011

    Report

    Report Number
    1219930-2011-00245
    Event Type
    Injury
    Date Received
    March 29, 2011
    Report Date
    March 25, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: AFTER FIRING THE PRODUCT, ITS JAW DID NOT OPEN. SO HE HAD TO RE-STAPLE WITH LARGER MARGIN OF TISSUE THAN IT WAS SUPPOSE TO BE REMOVED. THE SURGEON ALSO HAD TO USE MORE STAPLES THAN IT WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ROTICULATOR 60-3.5 SULU DISPOSABLE STAPLER GDW UNITED STATES SURGICAL N0H0649

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability