BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24478428 · Received March 2, 2026

    Report

    Report Number
    2955842-2026-14670
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    January 29, 2026
    Report Date
    February 27, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 REPLACED THE VIDEO PROCESSOR (VP) TO RESOLVE THE REPORTED PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE VP WAS ANALYZED, AND ERROR 319 WAS CONFIRMED IN THE LOG. UPON VISUAL INSPECTION, THE FILTER WAS DIRTY. THE VP WAS INSTALLED ONTO THE GOLDEN SYSTEM WHERE A NODE WAS NOT PRESENT ON THE LAPTOP APP, AND UPON POWERING UP ERROR 319 APPEARED. THE PROBABLE ROOT CAUSE WAS ATTRIBUTED TO A DEFECTIVE DUAL WINDOW APPLIANCE (DWA) BOARD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO A PROCEDURE, ERROR 319 OCCURRED ON THE VIDEO PROCESSOR (VP) AND WAS NOT RESOLVED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2713 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-19 N/A 00886874110898

    Patients

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