BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA ULTRA

    MDR report key: 2888578 · Received December 14, 2012

    Report

    Report Number
    2888578
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL, A DIVISION OF TYCO HEALTHCARE
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC APPENDECTOMY, THE SURGEON ATTEMPTED TO USE THE COVIDIEN ENDO GIA ULTRA UNIVERSAL STAPLER. THE STAPLER FIRED ONCE AND THEN FAILED TO FIRE A SECOND AND THIRD TIME. THE INSTRUMENT WAS REMOVED FROM THE FIELD, AND THE SURGEON UTILIZED A NU-KNIT ABSORBABLE HEMOSTAT INSTEAD. THERE WERE NO ADVERSE AFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ULTRA STAPLER, SURGICAL GDW COVIDIEN, FORMERLY US SURGICAL, A DIVISION OF TYCO HEALTHCARE EGIAUSTND N2G0578UMX

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR