BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24691616 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-17926
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    February 28, 2025
    Report Date
    March 25, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119662
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 PARTS TO RESOLVE ISSUE. 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 (FA). THE COMMON COMPUTE CONTROLLER (CCC) WAS ANALYZED THE CCC WAS VISUALLY INSPECTED, WHERE NO ISSUES WERE FOUND. UNIT WAS INSTALLED ON THE KNOWN GOOD IN-HOUSE SYSTEM AND THE VISION SIDE CART (VSC) MONITOR COULD NOT SHOW FULL DISPLAY ON THE SCREEN. THE VSC TOUCHSCREEN SHOWED "INSUFFLATOR DISABLED" MESSAGE. VSC POWER BUTTON KEPT FLASHING BLUE AND SYSTEM WOULD NOT COMPLETE FULL POWER UP SEQUENCE. THE UNIT WAS TAKEN TO A PROGRAMMING STATION WHERE IT WAS CONFIRMED TO BE BRICKED. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. THE ROOT CAUSE WAS DETERMINED TO BE A BRICKED CCC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI ASSISTED SURGICAL PROCEDURE, THE ROBOTICS COORDINATOR CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THE SYSTEM WON'T POWER ON ALL THE WAY. THE LIVE LOGS WEREN'T AVAILABLE AT THE TIME OF THE CALL. THE TSE ASKED WHAT THE POWER BUTTON WERE LOOKING LIKE. THE PATIENT CART AND CONSOLE HAVE SOLID BLUE AND VISION CART KEEPS BLINKING BLUE. AFTER HARD POWER CYCLE OF VISION CART POWER BUTTONS ARE THE SAME. THE TSE HAD THE CUSTOMER DISCONNECT BLUE FIBER CABLES FOR CONSOLE AND ROBOT STILL POWER BUTTON FLASHES ON TOWER AND SAYS INSUFFLATOR DISABLED. THE TSE HAD THE CUSTOMER POWER ON THE CONSOLE AND ROBOT BY ITSELF AND BOTH POWERED UP GOOD. THE CUSTOMER IS TRYING TO FIND ANOTHER SYSTEM TO USE FOR THE CASE. THE PROCEDURE WAS ABORTED TO ANOTHER DV SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269110 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-45 N/A 00886874119662

    Patients

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