BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24709847 · Received March 30, 2026

    Report

    Report Number
    2955842-2026-19091
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    October 27, 2025
    Report Date
    March 26, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119716
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    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. FSE REPLACED THE SYSTEM POWER MANAGER (SPM), VISION SIDE CART (VSC) COMMON COMPUTE CONTROLLER (CCC) AND FIBER OPTIC CABLES 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 SPM WAS ANALYZED AND ERROR CODE 31089 WAS IDENTIFIED INDICATING THAT THE FAULT OCCURRED IN THE FIELD. DURING VISUAL INSPECTION, NO VISIBLE DAMAGE WAS OBSERVED ON EXTERIOR AND PORTS OF THE UNIT. THE UNIT WAS INSTALLED IN THE GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS INTENDED. THEN, THE GOLDEN SYSTEM WAS DISCONNECTED FROM THE AC POWER CORD TO TEST IF THE SPM WOULD RECHARGE. THE COMPONENT FUNCTIONED AS EXPECTED WHEN AC POWER WAS RECONNECTED. ALSO, THE SYSTEM SAT IDLE FOR 30 MINS AND FUNCTIONED AS EXPECTED. THE SYSTEM WAS SET TO RUN 10 POWER CYCLES. ONCE TESTING WAS COMPLETED, THE SYSTEM ERROR LOGS WAS INSPECTED BUT NO ERRORS COULD BE IDENTIFIED. THE VSC CCC WAS ANALYZED AND IN LIGHTHOUSE, THIS ERROR 31089, FOUND INDICATING HARDWARE ON AN AURORA COMM LINK WAS DETECTED AND CONFIRMING THAT THIS FAULT DID OCCUR IN THE FIELD, FOLLOWED BY ERROR 307 INDICATING A NODE WAS NOT PRESENT. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THIS VSC CCC CFG WAS INSTALLED, SUCCESSFULLY PROGRAMMED AND TESTED ON THE DV5 IN HOUSE GOLDEN SYSTEM, WITH NO ISSUE, NO ERRORS TRIGGERED ON STARTUP. MULTIPLE POWER CYCLES WERE RUN WITH NO FAILURES AND NO ERRORS TRIGGERED. ALSO, THIS UNIT WAS LEFT IDLE FOR 1.5 HOURS IN NORMAL MODE, WITH NO ISSUE AND NO ERRORS TRIGGERED. FIBER LIGHT LEVELS ON ALL CHANNELS, AND ALL CHANNELS WERE WELL BEYOND NORMAL RANGE. THE FIBER OPTIC CABLE WAS ANALYZED AND THE ISSUE WAS CONFIRMED VIA ERROR LOGS. THE ARMORED FIBER OPTIC CABLE WAS VISUALLY INSPECTED, WHERE NO ISSUES WERE FOUND. THE UNIT WAS INSTALLED ONTO A KNOWN GOOD SYSTEM AND POWERED ON WITH NO ISSUES. THE FIBER LIGHT LEVELS WERE INSPECTED, WHERE THEY WERE SEEN TO BE WITHIN THE NORMAL RANGE. THE SYSTEM WAS LEFT TO IDLE FOR THREE HOURS, AND POWER CYCLED FIVE TIMES WITH NO ISSUES. THE FIBER OPTIC CABLE WAS ANALYZED AND THE ISSUE WAS CONFIRMED VIA ERROR LOGS. THE ARMORED FIBER OPTIC CABLE WAS VISUALLY INSPECTED, WHERE NO ISSUES WERE FOUND. THE UNIT WAS INSTALLED ONTO A KNOWN GOOD SYSTEM AND POWERED ON WITH NO ISSUES. THE SYSTEM WAS LEFT TO IDLE FOR 18 HOURS, AND POWER CYCLED FIVE TIMES WITH NO ISSUES. FOR THE SPM, VSC CCC AND FIBER OPTIC CABLES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) ON A NON-RECOVERABLE ERROR. THE TSE NOTED A 31089 ERROR POINTING TO THE VISION SIDE CART (VSC) (FIBER PORT 3) TO THE PATIENT SIDE CART (PSC), WHICH IS A SEPARATE, UNRELATED ERROR. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374188 DAVINCI 5 PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380747-40 N/A 00886874119716

    Patients

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