BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA* TRI-STAPLE RR 60MM ET RELOAD

    MDR report key: 6148766 · Received December 6, 2016

    Report

    Report Number
    1219930-2016-01293
    Event Type
    Malfunction
    Date Received
    December 6, 2016
    Date of Event
    November 10, 2016
    Report Date
    November 10, 2016
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    ORQ
    PMA / PMN Number
    K133938
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A SLEEVE GASTRECTOMY PROCEDURE, THE RELOAD MISFIRED. IT ONLY FIRED PARTIALLY AND STOPPED. IT WAS USED WITH A POWERED STAPLER HANDLE AND ALL OF THE LIGHTS WERE ILLUMINATED AS NORMAL. A NEW POWERED STAPLER HANDLE AND A NEW RELOAD WERE USED AND THE SAME THING HAPPENED. THE DEVICE WAS TESTED AFTERWARDS WITH A DIFFERENT RELOAD AND THE STAPLER WORKED FINE. THE STAPLE LINE WAS INCOMPLETE, SO IT WAS RE-STAPLED WITH A MANUAL HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800024 ENDO GIA* TRI-STAPLE RR 60MM ET RELOAD MESH, SURGICAL, DEPLOYER ORQ COVIDIEN, FORMERLY US SURGICAL A DIVISON EGIATRS60AXT N6H0875KX

    Patients

    Seq Age Sex Outcome Treatment
    1 POWERED STAPLER