BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA ULTRA UNIVERSAL STAPLER

    MDR report key: 1780801 · Received July 27, 2010

    Report

    Report Number
    1219930-2010-00582
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 12, 2010
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: SLEEVE GASTRECTOMY. ACCORDING TO THE REPORTER: THE DEVICE STAPLED PROPERLY (TEST WITH METHYLENE BLUE) BUT THE HEMOSTASIS WAS NOT COMPLETE. BLEEDING OCCURRED ALL ALONG THE DIGESTIVE TUBE AND THE SURGEON FIRST TRIED A BIPOLAR SEALING INSTRUMENT, BUT IT DID NOT WORK. THE SURGEON THEN COMPLETED WITH THREAD. THE PT DID NOT SUFFER FROM HIGH BLOOD PRESSURE AND WAS NOT TAKING B. BLOCKERS. THE OPERATION WAS EXTENDED BY AN HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EGIA ULTRA UNIVERSAL STAPLER DISPOSABLE STAPLER GDW UNITED STATES SURGICAL N0C0461U

    Patients

    Seq Age Sex Outcome Treatment
    1 Other EXP DATE: 3/31/15, MANUFACTURE DATE: 3/2010| EGIA60AMT, LOT#: N0C0595U| EGIA 60 ARTICULATING MED/THICK SULU