BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTUITIVE SURGICAL INC

    MDR report key: 7685107 · Received July 12, 2018

    Report

    Report Number
    MW5078356
    Event Type
    Malfunction
    Date Received
    July 12, 2018
    Date of Event
    June 6, 2018
    Report Date
    July 2, 2018
    Manufacturer
    INTUITIVE SURGICAL INC
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RATTLING SOUND COMING FROM INSTRUMENT HOUSING LEADING US TO BELIEVE THERE IS A BROKEN PIECE LOOSE INSIDE. INSTRUMENT REMOVED FROM FIELD AND ISOLATED. NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525943 INTUITIVE SURGICAL INC DA VINCI XI MEGA SUTURECUT NEEDLE DRIVER NAY INTUITIVE SURGICAL INC DA VICI XI N10180327

    Patients

    Seq Age Sex Outcome Treatment
    1