BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTUITIVE SURGICAL INC.

    MDR report key: 7104609 · Received December 8, 2017

    Report

    Report Number
    MW5073889
    Event Type
    Other
    Date Received
    December 8, 2017
    Date of Event
    March 29, 2017
    Report Date
    November 27, 2017
    Manufacturer
    INTUITIVE SURGICAL INC.
    Product Code
    NAY
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    GEARS MAKING STRANGE SOUNDS DURING CALIBRATION, ARM BLINKING YELLOW (MEANING ERROR) WILL NOT ALLOW ADVANCEMENT OF INSTRUMENT INTO PT. TESTED INSTRUMENT AFTER CASE COMPLETED, WITH SAME RESULTING ERRORS. MULTIPLE ATTEMPTS WERE TRIED WITH DIFFERENT STERILE DRAPES/ADAPTERS WITHOUT SATISFACTORY FUNCTIONING. NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881501 INTUITIVE SURGICAL INC. DA VINCI XI ENDOWRIST STAPLER 45 NAY INTUITIVE SURGICAL INC. DA VINCI XI S10160818-0014

    Patients

    Seq Age Sex Outcome Treatment
    1