BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI/INTUITIVE SURGICAL

    MDR report key: 4202573 · Received October 15, 2014

    Report

    Report Number
    4202573
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 13, 2014
    Manufacturer
    INTUITIVE SURGICAL
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN USING THE SINGLE-TOOTHED ROBOTIC TENACULUM, THE SURGEON NOTICED THAT SOME OF THE CABLES ON THE INSTRUMENT WERE FRAYED AND/OR BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656264 DAVINCI/INTUITIVE SURGICAL ROBOTIC TENACULUM NAY INTUITIVE SURGICAL 420207

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR