BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 23419484 · Received October 29, 2025

    Report

    Report Number
    2955842-2025-42225
    Event Type
    Injury
    Date Received
    October 29, 2025
    Date of Event
    October 3, 2025
    Report Date
    December 29, 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
    UK
    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 PREVENTATIVELY REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) GENERATOR PER THE CUSTOMER'S REQUEST. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: D9, H2, H3, H6, H11. DEVICE EVALUATION: INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) FOR FAILURE ANALYSIS EVALUATION. REVIEW OF THE ERROR LOG SHOWED NO EVIDENCE OF A FAULT OCCURRING IN THE FIELD. VISUAL INSPECTION FOUND NO ISSUES RELATED TO THE REPORTED EVENT. THE IESU WAS TESTED ON AN IN-HOUSE SYSTEM AND FUNCTIONED AS EXPECTED: ENERGIZING, CAUTERIZING, AND RECOGNIZING ALL INSTRUMENT PORTS. ADDITIONALLY, ALL NUTS ON THE REAR CONNECTORS WERE FOUND TO BE LOOSE. ADDITIONAL INFORMATION: A ONE-INCH SUPERFICIAL BURN WAS OBSERVED AT THE SITE WHERE THE CABLE CONNECTED TO THE DIATHERMY PAD ON THE PATIENT¿S LEFT THIGH, AFTER THE PAD WAS REMOVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY PROCEDURE, A ONE-INCH BURN WAS OBSERVED AT THE SITE OF THE DIATHERMY PAD AFTER ITS REMOVAL. DURING THE PROCEDURE, THE RED LIGHT ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU) GENERATOR SIGNALED AN ERROR AND A MESSAGE SUGGESTING AN ISSUE WITH THE DIATHERMY PAD. CONSEQUENTLY, THE MONOPOLAR ENERGY STOPPED FUNCTIONING. TO ADDRESS THE ISSUE, THE DIATHERMY PAD WAS REPOSITIONED, WHICH RESOLVED THE ERROR, AND THE INDICATOR LIGHT TURNED GREEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED ROBOTICALLY; HOWEVER, THE PATIENT WAS FOUND TO HAVE SUSTAINED A BURN AT THE SITE OF THE DIATHERMY PAD. THE SEVERITY OF THE BURN, AS WELL AS ANY SUBSEQUENT MEDICAL INTERVENTIONS THAT MAY HAVE BEEN PERFORMED, REMAINS UNKNOWN. AN INTUITIVE SURGICAL INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) WAS NOTIFIED THAT MULTIPLE GROUNDING PAD ERRORS HAD OCCURRED DURING THE PROCEDURE, AND THAT THE GROUNDING PAD HAD BEEN PRESSED ONTO THE PATIENT. AN ISI FIELD SERVICE ENGINEER (FSE) WAS REQUESTED TO FURTHER INVESTIGATE THE INCIDENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2686830 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC N/A N/A 00886874110898

    Patients

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