BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 24279563 · Received February 6, 2026

    Report

    Report Number
    2955842-2026-03582
    Event Type
    Malfunction
    Date Received
    February 6, 2026
    Date of Event
    October 20, 2025
    Report Date
    March 19, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE POWER SUPPLY SWITCHERS WERE ANALYZED, AND THE REPORTED PROBLEM WAS CONFIRMED BUT NOT REPLICATED. IN THE SYSTEM LOGS, THE 418 ERROR WAS FOUND, INDICATING THAT ONE OF THE REDUNDANT POWER SUPPLIES WAS OPERATING BELOW MINIMUM, CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNITS WERE INSTALLED ONTO A GOLDEN SYSTEM AND FUNCTIONED AS EXPECTED. NO ERROR 418 WAS TRIGGERED DURING THE STARTUP AND 10 POWER CYCLES OF THE SYSTEM. THE SYSTEM POWER MANAGER (SPM) STATUS WAS CHECKED AND NO FAULTS WERE DETECTED. THE MEASURED VOLTAGE AND CURRENT VALUES WERE CONSISTENT WITH THOSE OBSERVED IN THE GOLDEN UNIT. FURTHERMORE, THE SPM WAS ANALYZED, AND THE REPORTED PROBLEM WAS NOT REPLICATED. A REVIEW OF SYSTEM LOGS DID NOT IDENTIFY ANY ERRORS INDICATING THAT THE REPORTED FAULT OCCURRED IN THE FIELD. VISUAL INSPECTION WAS PERFORMED AND NO ISSUES RELATED TO THE REPORTED EVENT WERE IDENTIFIED. THE SPM WAS INSTALLED ON A GOLDEN SYSTEM, WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THE SYSTEM WAS THEN CONFIGURED TO PERFORM 10 POWER CYCLES FOLLOWED BY A ONE-HOUR IDLE PERIOD. AFTER TESTING WAS COMPLETED, THE SYSTEM ERROR LOGS WERE REVIEWED AND NO ERRORS WERE IDENTIFIED. A BATTERY DISCHARGE TEST WAS ALSO PERFORMED ON THE PATIENT SIDE CART. AFTER 1 HOUR AND 30 MINUTES OF DISCHARGE, THE BATTERY MEASURED 38.777 V WITH A CURRENT OF -10.895 A AND A STATE OF CHARGE (SOC) OF 67%. AFTER ONE HOUR OF RECHARGE, THE BATTERY MEASURED 43.683 V WITH A CURRENT OF 0.809 A AND AN SOC OF 99%. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION. WHILE A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED SINCE THE REPORTED COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING, THE POTENTIAL ROOT CAUSE FOR THIS FAILURE CAN BE ATTRIBUTED TO TRANSIENT ELECTRICAL ISSUES FROM POWER SUPPLY SWITCHERS.

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER (FSE) INVESTIGATED THE SYSTEM ISSUE AND REPLACED MEDICAL GRADE POWER SUPPLY (MGPS) 1 AND 2, AND THE SYSTEM POWER MANAGER (SPM) TO RESOLVE THE ISSUE. THE COMPONENTS WERE REQUESTED TO BE RETURNED FOR EVALUATION, BUT THE PRODUCTS HAVE NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT. THE INVESTIGATION TO DETERMINE THE CAUSE OF THIS REPORTED EVENT IS CURRENTLY IN PROGRESS. AS SUCH, THE PROBABLE ROOT CAUSE CANNOT YET BE DETERMINED BASED ON THE INFORMATION PROVIDED.

    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 TRAINING/DEMO OF THE DA VINCI SYSTEM, REDUNDANT MEDICAL GRADE POWER SUPPLY (RMGPS) 1 AND 2 WERE CAUSING ISSUES WITH THE PATIENT SIDE CART (PSC). THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278207 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-54 N/A 00886874110720

    Patients

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