BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23614033 · Received November 21, 2025

    Report

    Report Number
    2955842-2025-45844
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Date of Event
    November 12, 2025
    Report Date
    February 24, 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
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE HIGH RESOLUTION STEREO VIEWER (HRSV) WAS ANALYZED AND FOUND IN SYSTEM LOGS THE ERROR 119 WAS FOUND INDICATING THE FAILURE OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUE WAS FOUND THAT WOULD RELATE TO THE COMPLAINT. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE HRSV DISPLAYED VERTICAL LINES DOWN THE DISPLAY, SUCCESSFULLY REPLICATING THE REPORTED COMPLAINT. THE COMPLAINT REGARDING THE RIGHT EYE HAD VERTICAL STRIPES WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO AN ELECTRICAL COMPONENT ISSUE IN THE HRSV.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL INC., (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE REPLACED THE HIGH-RESOLUTION STEREO VIEWER (HRSV) MONITOR ON SURGEON SIDE CONSOLE (SSC) TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE HRSV INVOLVED IN THIS COMPLAINT HAS NOT BEEN RECEIVED AND/OR TESTED BY FAILURE ANALYSIS AS OF THE DATE OF THIS REPORT. IF THE PRODUCT IS RECEIVED AND EVALUATED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SURGICAL PROCEDURE, THE RIGHT EYE ON HIGH RESOLUTION STEREO VIEWER (HRSV) OF SURGEON SIDE CONSOLE (SSC) HAD VERTICAL STRIPES DESPITE OF PREVIOUS REPAIRS PERFORMED BY AN INTUITIVE SURGICAL INC., (ISI) FIELD SERVICE ENGINEER (FSE). THE REPORTED SYSTEM WAS A DUAL CONSOLE SYSTEM THEREFORE PROCEDURE WAS CONTINUED WITHOUT ANY INTERRUPTIONS. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC., (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE EVENT DATE FOR REPORTED INCIDENT WAS VERIFIED. IT WAS STATED THAT STAFF WAS ABLE TO COMPLETE THE PROCEDURE WITH SECOND SSC AS IT WAS A DUAL CONSOLE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2463113 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-17 N/A 00886874110744

    Patients

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