BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA ULTRA UNIVERSAL STAPLER

    MDR report key: 2032578 · Received March 22, 2011

    Report

    Report Number
    1219930-2011-00222
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    UNITED STATES SURGICAL A
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAP APPENDECTOMY. ACCORDING TO THE REPORTER: AS THE SURGEON WAS FIRING THE STAPLER, IT GOT HARDER WITH EACH SQUEEZE. AFTER THE FIRST TWO SQUEEZES, IT MADE A FUNNY CRUNCH SOUND. AFTER LOOKING AT THE RELOAD POST FIRING, IT LOOKS LIKE THE PUSHER BARS ARE NOT COMPLETELY DEPLOYED IN THE MID-SECTION OF THE CARTRIDGE. THE KNIFE BLADE CUT, BUT STAPLES DID NOT FORM IN THE PROPER B-SHAPE ACROSS THE WHOLE STAPLE LINE. THERE WERE UNFORMED STAPLES THAT CAME OUT OF THE CARTRIDGE. THEY HAD TO OPEN AND RESECT ADDITIONAL TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EGIA ULTRA UNIVERSAL STAPLER DISPOSABLE STAPLER GDW UNITED STATES SURGICAL A N0M0622UK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Disability ENDO GIA ROTICULATOR 60-3.5 SULU,(B)(4)