BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24694602 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-17925
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    March 13, 2025
    Report Date
    March 25, 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
    NJ, 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 COMMON COMPUTE CONTROLLER (CCC) AND THE CARDCAGE 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 CCC WAS ANALYZED AND UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED FAILURE. THE CCC WAS INSTALLED AND TESTED ON AN IN-HOUSE EFT SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THE VSC MONITOR COULD NOT SHOW FULL DISPLAY ON THE SCREEN AND THE VISION CART POWER BUTTON NOT STOP BLINKING BLUE WITH A MESSAGE OF INSUFFLATOR DISABLED. SYSTEM WAS NOT BE ABLE TO PROGRAM. PSC IS CONNECTING BUT NEVER COMPLETED. UNIT WAS INSTALLED INTO TEST BENCH AND POWERED ON WITH A POWER SUPPLY. UNIT WAS CONNECTED TO PC AND IDENTIFIED THE TEGRA MODULE WAS VISIBLE. THIS UNIT IS CONFIRMED TO BE BRICKED PER DOCUMENT (B)(4). THE CARDCAGE WAS ANALYZED AND THIS ISSUE IS NOT ASSOCIATED WITH AN ERROR, SO IT COULD NOT BE CONFIRMED VIA LIGHTHOUSE. THE CARDCAGE WAS VISUALLY INSPECTED, WHERE NO ISSUES RELATING TO THE COMPLAINT WERE FOUND. THE UNIT WAS INSTALLED ONTO A KNOWN GOOD SYSTEM AND POWERED ON WHERE THE ROBOT COULD NOT BE SEEN. AN ABA SWAP WAS PERFORMED ON THE CCC WHERE IT WAS CONFIRMED TO BE THE ISSUE. THE CCC WAS THEN TAKEN TO A PROGRAMMING STATION WHERE IT WAS CONFIRMED BRICKED THROUGH VMWARE. THE COMPLAINT WAS CONFIRMED BASED ON THE FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. FOR THE CCC, IT WAS CONCLUDED THAT BRICKED CCC WAS FOUND TO BE THE ROOT CAUSE OF THE REPORTED FAILURE. FOR THE CARDCAGE, 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 FIELD SERVICE ENGINEER (FSE) CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THE SYSTEM WOULDN'T POWER ON ALL THE WAY. THE FSE STATED THE VISION CART POWER BUTTON IS BLINKING BLUE AND WON'T POWER UP ALL THE WAY. PRIOR TO CALLING IN THE FSE HARD POWER CYCLED THE VISION CART AND STILL WON'T POWER UP ALL THE WAY. PATIENT CART HAS MESSAGE NOT CONNECTED TO VISION CART. THE TSE HAD FSE DISCONNECT THE PATIENT CART AND SURGEON CONSOLE. THEN POWER EVERYTHING UP IN NORMAL MODE AND PATIENT CART AND CONSOLE POWER UP NORMALLY BUT PATIENT CART DID HAVE A LOW BATTERY INDICATOR ON THE LED DISPLAY OF LESS THAN 10 PERCENT CHARGED. THE VISION CART STILL WOULDN'T COME UP AND KEPT BLINKING. IT APPEARS AT ONE POINT THE SYSTEM LOSS POWER INDICATED BY PATIENT CART. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174725 DAVINCI 5 PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380747-41 N/A 00886874119716

    Patients

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