BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA ULTRA UNIVERSAL XL STAPLER

    MDR report key: 2190459 · Received July 29, 2011

    Report

    Report Number
    1219930-2011-00632
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 18, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K061095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: SLEEVE GASTRECTOMY. ACCORDING TO THE REPORTER: THE STAPLER JAMMED HALFWAY THROUGH THE FIRING. MULTIPLE CRACKS OF THE HANDLE OCCURRED. THE SURGEON WAS FORCED TO RESECT THE STAPLE LINE. THE SURGEON CONTINUED THE OPERATION USING A DIFFERENT BRAND STAPLER FOR THE BOTTOM OF THE SLEEVE, THEN CHANGED TO THE DEVICE FOR THE TOP PORTION OF THE SLEEVE. THE MALFORMED STAPLE LINE WAS RESECTED AND NEW LINE WAS PLACED PROXIMAL. OPERATIVE TIME WAS EXTENDED LESS THAN 30 MINUTES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability K061095| DUET TRS 60 4.8MM STRAIGHT SULU: CAT # DUET6048