BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA 45 ARTICULATING MED/THICK SULU

    MDR report key: 2190456 · Received July 29, 2011

    Report

    Report Number
    1219930-2011-00633
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    June 23, 2011
    Report Date
    July 19, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GAG
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LUNG RESECTION. ACCORDING TO THE REPORTER: THE RELOAD WAS PLACED AROUND THE LUNG. THE RELOAD CLOSED AROUND THE TISSUE AND THE GREEN BUTTON WAS PRESSED ON THE HANDLE BUT THE DEVICE WOULD NOT FIRE. THE DEVICE LOCKED AROUND THE TISSUE AND THE SURGEON COULD NOT OPEN THE JAWS. ANOTHER STAPLER WAS OPENED AND FIRED TO THE LATERAL SIDE OF THE DEFECTIVE RELOAD. UNANTICIPATED TISSUE LOSS OCCURRED WITH THE DEFECTIVE RELOAD. THE SECOND RELOAD WORKED CORRECTLY WITH A NEW HANDLE. NO SIGNIFICANT BLEEDING WAS REPORTED. A DELAY IN OPERATIVE TIME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EGIA 45 ARTICULATING MED/THICK SULU DISPOSABLE SURGICAL STAPLING DEVICE GAG UNITED STATES SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other EGIA ULTRA UNIVERSAL SHORT STAPLER: CAT#EGIAUSHORT| (B)(4)