BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 24435504 · Received February 24, 2026

    Report

    Report Number
    2955842-2026-05456
    Event Type
    Injury
    Date Received
    February 24, 2026
    Date of Event
    January 29, 2026
    Report Date
    February 24, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN ISI FIELD SERVICE ENGINEER (FSE) WENT TO THE SITE TO FURTHER INVESTIGATE THE CUSTOMER REPORTED ISSUE. THE FSE PERFORMED A SYSTEM VERIFICATION AND COMPLETED ERBE INSTRUMENT RECOGNITION, ACTIVATION TESTS, AND CAUTERY TESTING DURING A SYSTEM TEST DRIVE WITHOUT ANY ISSUES. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A PATIENT WAS BURNED BY THE GENERATOR FROM THE VISION SIDE CART (VSC). THE CUSTOMER CONTACTED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE. THE TSE COULD NOT IDENTIFY ANY RELATED ERRORS IN THE SYSTEM LOGS. THE FOLLOWING INFORMATION IS UNKNOWN: THE CAUSE, LOCATION, AND SEVERITY OF THE BURN INJURY, WHAT MEDICAL/SURGICAL INTERVENTION WAS RENDERED DUE TO THE COMPLICATION, AND THE PROCEDURE OUTCOME. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260041 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-28 N/A 00886874110898

    Patients

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