BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIA STAPLER 3.5MM

    MDR report key: 3911829 · Received July 1, 2014

    Report

    Report Number
    3911829
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 1, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    O.R. MANAGER WAS MADE AWARE THAT DR HAD A PROBLEM WITH A GIA STAPLER. HE REPORTED THE 3.5 MM STAPLER FAILED TO CLOSE ALL THE WAY WHILE HE WAS CLOSING BOWEL. FOR THE 10 MM OF BOWEL HE WAS CLOSING, THE STAPLER CLOSED 5MM AND FAILED TO CLOSE 5 MM. HE HAD TO REDO THE ANASTOMOSIS AND TAKE MORE SMALL AND LARGE BOWEL (3-4").

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381682 GIA STAPLER 3.5MM STAPLE, IMPLANTABLE GAG COVIDIEN * P4C0197X

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR