BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 23130118 · Received September 24, 2025

    Report

    Report Number
    2955842-2025-39122
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    September 10, 2025
    Report Date
    October 28, 2025
    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
    MI, US
    Reporter Occupation
    003

    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. THE FSE WENT ON-SITE AND REPLACED THE HIGH-RESOLUTION STEREO VIEWERS (HRSVS). THE SYSTEM WAS VERIFIED AND READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS ISSUED A RETURN MATERIAL AUTHORIZATION (RMA) TO HAVE THE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE UNITS INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE HIGH-RESOLUTION STEREO VIEWERS (HRSVS) FOR FAILURE ANALYSIS INVESTIGATION. THE UNITS WERE ANALYZED AND THE FOLLOWING INFORMATION WAS OBTAINED: HIGH-RESOLUTION STEREO VIEWER 1 (HRSV): UPON VISUAL INSPECTION, THERE IS NO ISSUE FOUND THAT WOULD RELATE TO THE COMPLAINT. THE UNIT WAS INSTALLED ONTO THE GOLDEN SYSTEM. THE SYSTEM TURNED ON IN NORMAL MODE AND THE IMAGE DISPLAY OF HRSV MONITOR WAS CLEAR AS THE OTHER HRSV, IT'S NOT DIM. THE SYSTEM RAN 10 POWER CYCLES, BUT THE REPORTED ISSUE COULD NOT REPRODUCE. THIS UNIT WAS FOUND TO BE FUNCTIONAL. HIGH-RESOLUTION STEREO VIEWER 2 (HRSV): UPON VISUAL INSPECTION, NO ISSUE FOUND THAT WOULD RELATE TO THE COMPLAINT. THE UNIT WAS INSTALLED ONTO THE GOLDEN SYSTEM. UPON TURNING ON THE SYSTEM, THE RIGHT HRSV WAS NOT AS BRIGHT AS THE LEFT HRSV. THE BRIGHTNESS WAS ADJUSTED BUT SAME RESULT, THE RIGHT HRSV MONITOR WAS STILL DIMMER COMPARED TO LEFT HRSV. SUCCESSFULLY REPLICATED THE COMPLAINT. THE PROBABLE ROOT CAUSE CAN BE ATTRIBUTED TO COMPONENT FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ABDOMINOPERINEAL RESECTION (APR) SURGICAL PROCEDURE USING A DUAL SURGEON SIDE CONSOLE (SSC) SETUP, THAT ONE OF THE SSC'S HIGH RESOLUTION STEREO VIEWER (HRSV) EYES WAS VERY DIM, AND THE SURGEON COULD NOT SEE OUT OF IT. THE CUSTOMER REBOOTED THE SYSTEM, BUT THE ISSUE REMAINED. THE SURGEON MOVED TO THE OTHER SURGEON SIDE CONSOLE (SSC) AND PROCEEDED WITH THE CASE. THERE WERE NO REPORTS OF PATIENT INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542177 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-23 N/A

    Patients

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