BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 23662352 · Received November 26, 2025

    Report

    Report Number
    2955842-2025-46113
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    October 30, 2025
    Report Date
    November 26, 2025
    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
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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 VISITED THE SITE AND REPLACED THE IESU GENERATOR DUE TO ERROR. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE IESU GENERATOR WAS ANALYZED AND FOUND THE REPORTED ISSUE WAS CONFIRMED WITH MULTIPLE U-04 ERRORS, ALONG WITH M-11 AND 2-8A ERRORS. INSPECTION FOUND RELATED ISSUES BUT COULD NOT REPLICATE THE EVENT. IESU LOGS SHOWED A C-00 ERROR CONSISTENT WITH SYSTEM LOGS. THE UNIT PASSED ALL RECOGNITION AND ENERGY TESTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED TO INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) THAT THEY WERE NOT ABLE TO FIRE ENERGY, AND THE CORDS WERE NOT WORKING. THE TSE CONFIRMED ERROR U-04 ERROR IN LOGS AND HAD CUSTOMER POWER CYCLE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE CUSTOMER DOCKED AND UNDOCKED TO FIRE ENERGY; HOWEVER, ISSUE PERSISTED. THE TSE RECOMMENDED TO TRY ANOTHER INSTRUMENT; HOWEVER, THE CUSTOMER WAS UNABLE TO FURTHER TROUBLESHOOT. THE PROCEDURE WAS ABORTED POST-ANESTHESIA AND PORTS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1912891 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-43 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES.