BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 22283265 · Received June 18, 2025

    Report

    Report Number
    2955842-2025-25601
    Event Type
    Injury
    Date Received
    June 18, 2025
    Date of Event
    May 27, 2025
    Report Date
    May 27, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. INSUFFICIENT INFORMATION WAS AVAILABLE FOR LOG REVIEW.

    Additional Manufacturer Narrative · 0

    UPDATED SECTION: H3. ADDITIONAL INFORMATION: AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPRODUCED THE CUSTOMER REPORTED PROBLEM THAT THE FINGER-SWITCH ON THE MONOPOLAR INSTRUMENT WAS BURNT. THE INTEGRATED ELECTRICAL SURGICAL UNIT WAS REPLACED, AND THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED PROCEDURE, THE SURGEON SUSTAINED A BURN WHILE USING AN UNSPECIFIED FINGER-SWITCH MONOPOLAR INSTRUMENT. THE UNSPECIFIED INSTRUMENT WAS REPORTEDLY NOT AN INTUITIVE PRODUCT. THE SEVERITY OF THE BURN AND WHETHER ANY MEDICAL TREATMENT WAS REQUIRED REMAIN UNKNOWN. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT DELAY OR FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864250 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-46 N/A 00886874110898

    Patients

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