BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EGIA 60 ARTICULATING MED/THICK SULU

    MDR report key: 4080365 · Received August 25, 2014

    Report

    Report Number
    1219930-2014-00767
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 12, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GAG
    PMA / PMN Number
    K083519
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: HEMICOLECTOMY. ACCORDING TO THE REPORTER: THE SURGEON LOADED THE FIRST LOAD INTO THE IDRIVE. THE THIRD LIGHT KEPT BLINKING AND THE RELOAD COULD NOT BE FIRED OR REMOVED. A SECOND RELOAD WAS OPENED AND USED, BUT IT ONLY FIRED PARTIALLY AND IT HAD TO BE PRIED OFF THE TISSUE. A THIRD ONE WAS OPENED, AND IT WORKED. A FOURTH ONE WAS ALSO OPENED AND USED AND THIS ONE ALSO WORKED. NO ADVERSE PT EFFECTS WERE REPORTED. NO REINFORCEMENT MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510609 EGIA 60 ARTICULATING MED/THICK SULU DISPOSABLE SURGICAL STAPLER GAG COVIDIEN, FORMERLY US SURGICAL N4E0805KX

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR IDRIVE ULTRA POWERED HANDLE 1, IDRVULTRA1, (B)(4)