BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI STAPLER 45

    MDR report key: 7658113 · Received July 3, 2018

    Report

    Report Number
    7658113
    Event Type
    Malfunction
    Date Received
    July 3, 2018
    Date of Event
    June 28, 2018
    Report Date
    June 29, 2018
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DAVINCI XI STAPLER 45 MALFUNCTIONED. NOT ALL OF THE STAPLES FIRED. LOT #T1-2180531-0027.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503203 DAVINCI XI STAPLER 45 STAPLE, IMPLANTED GDW INTUITIVE SURGICAL, INC. T1-2180531-0027

    Patients

    Seq Age Sex Outcome Treatment
    1