BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24622067 · Received March 17, 2026

    Report

    Report Number
    2955842-2026-16468
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    February 23, 2026
    Report Date
    March 17, 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
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) TO CORRECT THE REPORTED EVENT. 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 WAS ANALYZED AND FOUND THE REPORTED ISSUE WAS NOT CONFIRMED USING SYSTEM LOGS. M-1F ERROR LOGGED IS NOT OF CONCERN. INSPECTION DURING FA PROCESS WAS NOT ABLE TO CONFIRM OR REPLICATE THE REPORTED EVENT. FA INSPECTION ONLY TESTS FOR ACTIVATION VIA TONES; HANDHELD INSTRUMENTS NOT AVAILABLE/UTILIZED IN TEST OPERATIONS. UNIT TESTED ON SYSTEM, ALL OPERATIONS SUCCESSFUL VIA ALL PORTS. FOOTSWITCH ACTIVATION TONE OPERATIONS SUCCESSFUL. NO ERRORS IN ERBE LOGS. AS A RESULT OF THESE FINDINGS, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED BECAUSE THE UNIT IS AN OEM PRODUCT AND CANNOT BE OPENED ON SITE FOR FURTHER ANALYSIS. ERBE WILL BE SENT TO OEM FOR FURTHER INVESTIGATION. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    THE PROBABLE ROOT CAUSE OF THIS ISSUE IS ATTRIBUTED TO A FAULTY ELECTRICAL COMPONENT INSIDE THE ERBE GENERATOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THE ERBE FOOT PEDALS WERE NOT ACTIVATING ENERGY. THE ERBE WAS PROVIDING AUDIO INDICATION OF ENERGY DELIVERY, BUT THERE WAS NO OUTPUT. THE USER TURNED UP THE EFFECT LEVEL, WITH NO CHANGE. THERE WERE NO RELATED ERRORS IN THE SYSTEM LOGS. THE USER PROCEEDED WITH A 3RD PARTY GENERATOR. THE CUSTOMER WAS NOT DOCKED YET. THE INTUITIVE TECH SUPPORT ENGINEER (TSE) WALKED THE CALLER THROUGH A POWER CYCLE OF THE ERBE, BUT THEY WERE UNABLE TO CONFIRM IF THE FOOT PEDALS WERE WORKING.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416973 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-46 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1