BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24411303 · Received February 23, 2026

    Report

    Report Number
    2955842-2026-05353
    Event Type
    Malfunction
    Date Received
    February 23, 2026
    Date of Event
    January 23, 2026
    Report Date
    February 22, 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
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER¿S SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE CONFIRMED THE REPORTED ISSUE AND REPLACED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE DA VINCI PRODUCT INVOLVED WITH THE COMPLAINT AND COMPLETED THE FAILURE ANALYSIS. THE ISSUE COULD NOT BE CONFIRMED USING SYSTEM LOGS. HOWEVER, THE UNIT PRESENTED ERROR M-11. VISUAL INSPECTION FOUND THE UNIT WITH CRACK ON THE UPPER RIGHT CORNER OF THE BEZEL. THERE WERE ALSO SCRATCHES AND AREAS OF CHIPPED PAINT ON THE HOUSING COVER, AND THE LEFT REAR PORTION OF THE HOUSING WAS OBSERVED TO BE DENTED AND BENT. FURTHER FUNCTIONAL TESTING RESULTED IN ERROR U-02 APPEARING UPON STARTUP, AND A REVIEW OF THE INTERNAL SYSTEM LOG ADDITIONALLY SHOWED ERROR C-00. THE PROBABLE ROOT CAUSE COULD BE ATTRIBUTED TO A COMMUNICATION ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WAS AN ERROR U-02 ON THE ERBE GENERATOR. PRIOR TO CALLING THE CUSTOMER CONNECTED A BACKUP GENERATOR AND THEY ARE CONTINUING AS PLANNED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475175 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

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