BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24525736 · Received March 5, 2026

    Report

    Report Number
    2955842-2026-15167
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    February 9, 2026
    Report Date
    April 7, 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
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE HIGH RESOLUTION STEREO VIEWER (HRSV) TO PERFORM FAILURE ANALYSIS AND THE REPORTED FAILURE WAS REPLICATED DURING IN-HOUSE TESTING AND CONFIRMED VIA SYSTEM LOGS. UPON VISUAL INSPECTION, NO ISSUE WAS FOUND THAT WOULD RELATE TO THE COMPLAINT. THE HRSV WAS THEN INSTALLED ONTO THE GOLDEN SYSTEM. UPON POWERING UP THE SYSTEM, THERE WAS NO IMAGE ON THE HRSV, IT WAS COMPLETELY BLACK. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO DISPLAY DEFECT PERTAINING TO THE HRSV MONITOR.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE WAS ABLE TO REPRODUCE THE ISSUE AND REPLACED THE HIGH RESOLUTION STEREO VIEWER (HRSV). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. AS OF THE DATE OF THIS REPORT, THE HRSV HAS NOT YET BEEN RECEIVED BY ISI FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WAS NO IMAGE DISPLAYED FOR THE LEFT HIGH RESOLUTION STEREO VIEWER (HRSV), AND THE DA VINCI LOGO DID NOT APPEAR. A HARD POWER CYCLE DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS ABORTED, AND NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446214 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-10 N/A 00886874110744

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DA VINCI INSTRUMENTS AND ACCESSORIES.