BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA 45 ARTICULATING VAS/MED SULU

    MDR report key: 2202554 · Received August 8, 2011

    Report

    Report Number
    1219930-2011-00662
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 1, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOBECTOMY. ACCORDING TO THE REPORTER: TWO RELOADS MISFIRED (STAPLES DID NOT FORM PROPERLY) ON 2 BRANCHES OF THE PV (BOTH ON THE "GO" SIDE). IT WAS NOTICED ON THE GO SIDE THAT THE STAPLE LINE WAS NOT FORMED AND WAS LEAKING BLOOD ALONG THE STAPLE LINE. THE STAPLES THEMSELVES DID NOT LOOK LIKE THEY NORMALLY DO, AND OOZED/SQUIRTED WORSE THAN EVER. THEY OPENED UP A REGULAR #(B)(4) FOR THE PA AND IT WORKED FINE. TO STOP THE BLEEDING THE DOCTOR USED SUTURE ALONG THE STAPLE LINE. THE CASE WAS EXTENDED BY 20 MINUTES. THERE IS TISSUE WITHIN THE STAPLE LINES, WHICH HE RESECTED. THE SURGEON OVER SEWED THE "STAY" STAPLE LINES TO STOP THE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EGIA 45 ARTICULATING VAS/MED SULU DISPOSABLE STAPLER GDW UNITED STATES SURGICAL V1F0004

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Disability 04/30/2016, (B)(4)| EGIAUSTND, LOT: N1D0569UK, MANUF: 04/2011, EXP:| EGIA ULTRA UNIVERSAL STAPLER: CATALOG #: