BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 25204502 · Received May 18, 2026

    Report

    Report Number
    2955842-2026-25487
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    April 2, 2026
    Report Date
    May 18, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE ISSUE WAS RESOLVED AFTER THE CUSTOMER CLEARED THE ERROR ON THE VISION CART. NO SITE VISIT WAS CONDUCTED. THE SYSTEM WAS WORKING PROPERLY, AND NO ADDITIONAL ACTION WAS REQUIRED AS THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, WHEN THE INTEGRATED TABLE MOTION (ITM) CONNECTION WAS LOST, THE MASTER TOOL MANIPULATOR (MTM) DRIFTED AND CAUSED UNCONTROLLED MOVEMENT. THE SURGICAL STAFF OBSERVED THAT THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT'S TIP MOVED A FEW CENTIMETERS AFTER THE CONNECTION LOSS WHILE THE SURGEON¿S HEAD REMAINED IN THE CONSOLE. THE SURGEON INITIALLY KEPT THEIR HANDS ON THE MTM BUT REMOVED THEM ONCE DRIFTING BEGAN AND WHILE THEIR HEAD WAS STILL IN THE HIGH RESOLUTION STEREO VIEWER (HRSV). THE ISSUE WAS RESOLVED BY CLEARING THE ERROR ON THE VISION CART, THOUGH THE ITM PROBLEM PERSISTED UNTIL A FULL SYSTEM RESET. A VIDEO RECORDING OF THE PROCEDURE EXISTS, AND THE CUSTOMER IS ASKING HOW TO GRANT INTUITIVE SURGICAL ACCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397048 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-06 N/A 00886874110744

    Patients

    Seq Age Sex Outcome Treatment
    1