BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 22893648 · Received August 26, 2025

    Report

    Report Number
    2955842-2025-34964
    Event Type
    Injury
    Date Received
    August 26, 2025
    Date of Event
    August 4, 2025
    Report Date
    August 4, 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
    GM
    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 CORE REDUNDANT POWER TRAY ASSEMBLY, AND THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE REDUNDANT POWER TRAY ASSEMBLY FOR FAILURE ANALYSIS. IN THE REMOTE LOGS, THE ERROR WAS FOUND, INDICATING A POWER TRAY FAILURE AND CONFIRMING THE FAULT THAT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO A SYSTEM, AND AFTER STARTING, THE UNIT FAILED WITH THE ERROR. THE ISSUE WAS REPLICATED AFTER MULTIPLE POWER CYCLES. BOTH POWER SUPPLIES WERE CHECKED AND FOUND TO BE FUNCTIONING PROPERLY. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS COMPLETED, AND THE INVESTIGATION REVEALED THE FOLLOWING POSSIBLE RELATED SYSTEM ERRORS: POWER DISTRIBUTION BOARD ADC FAULT - AN ANALOG TO DIGITAL CONVERTER VOLTAGE OUT-OF-RANGE ON CHANNEL 7, 12.0V.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY PROCEDURE; A RECURRING ERROR RENDERED THE SYSTEM UNAVAILABLE FOR THE COMPLETION OF THE PROCEDURE. DESPITE MULTIPLE ATTEMPTS TO RESOLVE THE ISSUE BY POWER CYCLING THE SYSTEM, THE ERROR PERSISTED. AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CALLED, WHO CONFIRMED THE ERROR. AT THE TIME OF THE SYSTEM ERROR, THE PROCEDURE WAS ALREADY WELL ADVANCED, WITH THE UTERUS HAVING BEEN MORCELLATED AND REMOVED VAGINALLY, ELIMINATING THE NEED FOR CONVERSION TO LAPAROSCOPIC OR OPEN SURGERY. CONSEQUENTLY, THE SURGEON HAD TO UNEXPECTEDLY COMPLETE THE PROCEDURE BY MANUALLY SUTURING THE VAGINAL CUFF, A TASK TYPICALLY PERFORMED USING THE ROBOTIC SYSTEM. THERE WERE NO CONSEQUENCES FOR THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2723453 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-46 N/A 00886874110898

    Patients

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