BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI XI

    MDR report key: 24709900 · Received March 30, 2026

    Report

    Report Number
    2955842-2026-18945
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    November 14, 2025
    Report Date
    March 26, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115374
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    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 POWER SUPPLY SWITCHER AND GENERIC POWER DISTRIBUTOR (GPD) TO SOLVE THE REPORTED ISSUES. 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 POWER SUPPLY SWITCHER WAS ANALYZED AND NO RELATED ERRORS WERE FOUND IN ARTEMIS. UPON VISUAL INSPECTION, THE FAN OF THE MEDICAL GRADE POWER SUPPLY (MGPS) HAS DUST ALL OVER THE BLADES. THE UNIT WAS THEN INSTALLED ONTO THE GOLDEN SYSTEM WHERE THE UNIT FUNCTIONED AS EXPECTED, THE SURGEON SIDE CONSOLE (SSC) TURNED ON NORMALLY WITH NO ISSUE. THE SYSTEM RAN 10 POWER CYCLES BUT THE REPORTED ISSUE WAS NOT ABLE TO REPLICATE. THE ERROR LOGS WERE CHECKED BUT COULD NOT FIND ANY RELATE ERROR. THE GPD WAS ANALYZED AND IN ARTEMIS, NO ERROR WAS FOUND INDICATING THE FAULT. VISUAL INSPECTION, NO ISSUES WERE FOUND THAT ARE RELATED TO THE REPORTED ISSUE. THE GPD WAS INSTALLED ONTO THE GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THE GOLDEN SYSTEM WAS SET TO RUN 10 POWER CYCLES AND SITTING IDLE FOR ONE HOUR. ONCE TESTING WAS COMPLETED, THE SYSTEM ERROR LOGS WAS INSPECTED, BUT NO ERROR COULD BE IDENTIFIED. THE COMPLAINT WAS CONFIRMED BASED ON THE FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. FOR THE POWER SUPPLY SWITCHER AND GPD, THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON FAILURE ANALYSIS RESULTS. THE PRODUCT WAS VISUALLY INSPECTED AND EVALUATED FOR ITS MECHANICAL AND/OR ELECTRICAL CHARACTERISTICS. HOWEVER, THE FAILURE ANALYSIS INVESTIGATIONS AND IN-HOUSE TESTING OF THE RETURNED PRODUCT WERE NOT ABLE TO REPLICATE THE CUSTOMER REPORTED EVENT. NO ADDITIONAL ACTIONS ARE CURRENTLY REQUIRED GIVEN THAT THIS ISSUE WILL CONTINUE TO BE TRACKED PER (B)(4) (QUALITY DATA REVIEW MEETINGS).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START - PRE-ANESTHESIA OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SURGEON SIDE CONSOLE (SSC) WAS NOT TURNING ON. TECHNICAL SUPPORT ENGINEER (TSE) INFORMED SITE TO PERFORM A HARD POWER CYCLE. SSC WAS NOT TURNING ON AND NO AMBER LED LIGHT ON SSC. SITE INFORMED FAN SOUND WAS COMING FROM SSC. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147264 DA VINCI XI SURGEON SIDE CONSOLE, RECONDITIONED NAY INTUITIVE SURGICAL, INC 380723-14 00886874115374

    Patients

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