BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24283977 · Received February 6, 2026

    Report

    Report Number
    2955842-2026-03650
    Event Type
    Malfunction
    Date Received
    February 6, 2026
    Date of Event
    September 22, 2025
    Report Date
    March 19, 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
    FR
    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. FSE REPLACED THE HIGH-RESOLUTION STEREO VIEWER (HRSV) TO CORRECT THE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE HIGH-RESOLUTION STEREO VIEWER (HRVS) WAS ANALYZED AND FOUND TO BE IN SYSTEM LOGS, THE NOT RELATED ERROR 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 DID NOT DISPLAY ANY IMAGE, TOTALLY BLACK SCREEN. SUCCESSFULLY REPLICATING THE REPORTED COMPLAINT. THE COMPLAINT REGARDING LEFT EYE ON THE SURGEON CONSOLE WAS BLACK WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE CAN BE ATTRIBUTED TO NO IMAGE ON THE HRSV.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRAINING/DEMO OF THE DA VINCI SYSTEM, ONE EYE WAS BLACK ON THE SURGEON SIDE CONSOLE (SSC). PRIOR TO CALLING THE TECHNICAL SUPPORT ENGINEER (TSE), THE CALLER HAD POWER CYCLED THE SYSTEM WITHOUT IMPROVEMENT. THE SYSTEM WAS NOT CONNECTED TO THE NETWORK AT THE TIME OF THE CALL. THE TSE CONFIRMED WITH THE CALLER THAT THE VIDEO IMAGE ON THE VISION SIDE CART TOUCHSCREEN WAS FINE. TSE ASKED CALLER TO PERFORM A POWER CYCLE AND FLIP THE SURGEON SIDE CONSOLE (SSC) BREAKER AND RESEAT THE BLUE FIBER CABLE, BUT THE ISSUE DID NOT IMPROVE. TSE ASKED THE CALLER TO CHECK IF THE DA VINCI LOGO WAS PRESENT ON THE SSC LEFT EYE DURING POWER ON SEQUENCE, CALLER CONFIRMED THIS WAS TRUE BUT THE IMAGE TURNED BLACK RIGHT AFTER. CALLER STATED THEY WOULD ABANDON THE SSC AND PROCEED WITH A SINGLE SSC. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR 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
    152846 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-13 N/A 00886874110744

    Patients

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