BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EGIA ULTRA UNIVERSAL SHORT STAPLER

    MDR report key: 3192551 · Received June 19, 2013

    Report

    Report Number
    1219930-2013-00459
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 3, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LOW ANT RESECT DOUBLE STAPLE. ACCORDING TO THE REPORTER: AT THE 1ST FIRING ON THE RECTUM, THE DEVICE MADE A CRACKING SOUND AND THE HANDLE COULD NOT BE SQUEEZED AFTER THAT. THE SURGEON IMMEDIATELY REMOVED THE DEVICE FROM THE TISSUE AND USED ANOTHER CARTRIDGE TO COMPLETE THE PROCEDURE. THE TISSUE WAS DAMAGED WHEN THE DEVICE WAS REMOVED. THE DAMAGED PART WAS SUTURED. NO INFORMATION ABOUT THE USE OF REINFORCEMENT MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278882 EGIA ULTRA UNIVERSAL SHORT STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL N3B0015UMX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CAT # EGIARADMT, LOT # N3C0114UX, MFR 02/2013,| EXP DATE 02/28/2018, PMA 510(K) K083519| ENDO GIA MEDIUM/THICK RADIAL RELOAD,