BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTUITIVE SURGICAL INC. SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

    MDR report key: 7285736 · Received February 20, 2018

    Report

    Report Number
    MW5075388
    Event Type
    Malfunction
    Date Received
    February 20, 2018
    Date of Event
    January 18, 2018
    Report Date
    January 29, 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

    JAWS AT DISTAL END OF INSTRUMENT UNABLE TO CLOSE. INSTRUMENT UNUSABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126233 INTUITIVE SURGICAL INC. SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT DA VINCI XI, SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL INC. MEGA SUTURECUT NEEDLE DRIVER N10171010-0062

    Patients

    Seq Age Sex Outcome Treatment
    1