BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI HARMONIC CURVED SHEARS INSERT

    MDR report key: 1910922 · Received November 15, 2010

    Report

    Report Number
    1910922
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 15, 2010
    Manufacturer
    INTUITIVE SURGICAL
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    END PIECE BROKE OFF AND WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAVINCI HARMONIC CURVED SHEARS INSERT INSTRUMENT, ULTRASONIC SCALPEL, CURVED SHEARS NAY INTUITIVE SURGICAL 400169 M10100802

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR