BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22334116 · Received June 26, 2025

    Report

    Report Number
    2955842-2025-27449
    Event Type
    Malfunction
    Date Received
    June 26, 2025
    Date of Event
    June 3, 2025
    Report Date
    February 5, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE VIO INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) TO PERFORM FAILURE ANALYSIS (FA). FA WAS ABLE TO CONFIRM THE REPORTED COMPLAINT VIA SYSTEM LOGS AND REPRODUCED THE ISSUE DURING IN-HOUSE TESTING. DURING IESU CAUTERY ACTIVATION, THE M2 ERROR WAS FOUND, CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE PROBABLE ROOT CAUSE COULD BE ATTRIBUTED TO FAULTY ELECTRICAL COMPONENTS INSIDE THE IESU THROWING ERROR M-02. THIS ERROR INDICATES MODULE TIMEOUT.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE WAS ABLE TO REPRODUCE THE ISSUE AND REPLACED THE VIO INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. AS OF THE DATE OF THIS REPORT, THE IESU HAS NOT YET BEEN RECEIVED BY INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL TERRITORY ASSOCIATE (CTA) CALLED IN TO INFORM THAT THE VIO INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) SHOWED CONSTANT M-02 ERRORS AND DID NOT ACTIVATE. THE ISI TECHNICAL SUPPORT ENGINEER (TSE) GUIDED THE CALLER TO POWER CYCLE THE IESU AND USE A DIFFERENT POWER SOCKET. HOWEVER, THE ERROR STILL PERSISTED, AND THE ENERGY DID NOT ACTIVATE. THE SURGEON ELECTED TO CONTINUE THE PROCEDURE USING AN EXTERNAL GENERATOR WITH THE EXTERNAL FOOT PEDALS. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361292 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-46 N/A 00886874110898

    Patients

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