BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI XI

    MDR report key: 25289320 · Received May 26, 2026

    Report

    Report Number
    2955842-2026-26301
    Event Type
    Malfunction
    Date Received
    May 26, 2026
    Date of Event
    April 29, 2026
    Report Date
    May 26, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE REPLACED THE OPTOBUTTON AND THREADLOCKER COATED SCREW TO RESOLVE THE ISSUE. THE OPTOBUTTON CAME OFF LOOSE DURING THE CASE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE AFFECTED PARTS INVOLVED WITH THIS COMPLAINT ARE FIELD SCRAP ITEMS AND WILL NOT BE RETURNED TO ISI FOR FURTHER INVESTIGATION. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HAND CONTROL SWITCHES WERE DISABLED. TROUBLESHOOTING FIRST INVOLVED INSTRUCTING THE SITE TO PERFORM A POWER RESTART AND CYCLE THE SWITCHES. SUBSEQUENTLY, THE FINGER CLUTCH FELL OFF; THE SURGEON REATTACHED IT AND CONTINUED WITH THE CASE. LATER, THE VESSEL SEALER BECAME STUCK ON TISSUE, AND THE GRIP COULD NOT BE RELEASED. THE SAME ERROR CODE WAS RECEIVED AGAIN. TROUBLESHOOTING THEN INCLUDED POWER CYCLING THE SYSTEM, WHICH RESTORED CONTROL OF THE LEFT MASTER TOOL MANIPULATOR (MTM) AND RELEASED THE TISSUE. IT WAS ALSO ADVISED NOT TO USE THE LEFT OPTO BUTTONS DUE TO THE POSSIBILITY OF THEM BECOMING DISABLED AGAIN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE ISSUE OCCURRED WITH THE SURGEON¿S HEAD INSIDE THE SURGEON CONSOLE¿S HIGH RESOLUTION STEREO VIEWER. ONLY THE RUBBER ON THE HAND CONTROL HAD THE DAMAGE. THE DEVICE WAS INSPECTED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339934 DA VINCI XI SURGEON SIDE CONSOLE, RECONDITIONED NAY INTUITIVE SURGICAL, INC 380723-02 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1