BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIA

    MDR report key: 11391804 · Received March 1, 2021

    Report

    Report Number
    11391804
    Event Type
    Malfunction
    Date Received
    March 1, 2021
    Date of Event
    February 1, 2021
    Report Date
    February 23, 2021
    Manufacturer
    COVIDIEN LP
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 0

    COVIDIEN LP GIA UNIVERSAL STAPLER MISFIRE ONLY CUTTING THE COLON WITHOUT STAPLING THE TISSUE. AN ADDITIONAL ANASTOMOSIS NEEDED TO BE PERFORMED.

    Description of Event or Problem · 1

    COVIDIEN LP GIA UNIVERSAL STAPLER MISFIRE ONLY CUTTING THE COLON WITHOUT STAPLING THE TISSUE. AN ADDITIONAL ANASTOMOSIS NEEDED TO BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288512 GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP

    Patients

    Seq Age Sex Outcome Treatment
    1 15330 DA Other