BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24371328 · Received February 17, 2026

    Report

    Report Number
    2955842-2026-04703
    Event Type
    Malfunction
    Date Received
    February 17, 2026
    Date of Event
    January 27, 2026
    Report Date
    March 13, 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
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PATIENT DEMOGRAPHICS WERE SHARED.

    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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. THE FSE RESEATED THE CONNECTIONS OF THE SYSTEM WITH THE SURGEON SIDE CONSOLE (SSC). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION.

    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 CUSTOMER REPORTED TO TECHNICAL SERVICE ENGINEER (TSE) THAT ONE OF THE EYES ON THE SURGEON SIDE CONSOLE (SSC) WAS GOING BLACK. TSE VIEWED LOGS AND NOTED ERROR 45308 FOR THE RIGHT EYE AND ERROR 48200 FOR THE PERSONALITY MODULE SURGEON CONSOLE (PMSC). THE PROCEDURE WAS CONVERTED TO ANOTHER DV SYSTEM WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476416 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-15 N/A 00886874110744

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES