BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24552418 · Received March 9, 2026

    Report

    Report Number
    2955842-2026-15510
    Event Type
    Malfunction
    Date Received
    March 9, 2026
    Date of Event
    February 15, 2026
    Report Date
    April 28, 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
    IN, US
    Reporter Occupation
    NURSE
    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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. FSE WAS ABLE TO REPLICATE THE REPORTED ISSUE. FSE REPLACED THE COMMON COMPUTE CONTROLLER (CCC) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE REPORTED FAILURE WAS CONFIRMED, BUT TESTING SHOWED IT COULD BE REPLICATED WITHOUT INVOLVING THE TOWER CCC. DURING THE LIGHTHOUSE REVIEW, LOGS REVEALED ERRORS 31089, 170, AND 307, CONFIRMING THAT THE FAULT HAD OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND RELATED TO THE REPORTED EVENT. THE TOWER CCC WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THE FIBER OPTIC LIGHT LEVELS ON THE CCC WERE INSPECTED USING LOCAL HOST:8050, AND ALL VALUES WERE WITHIN EXPECTATIONS. TEN POWER CYCLES WERE PERFORMED, AND THE CCC WAS LEFT IN THE GOLDEN SYSTEM TO IDLE FOR 2 HOURS WITH NO ISSUES FOUND. AS A RESULT OF THESE FINDINGS, FAILURE ANALYSIS CONCLUDED THAT NO ROOT CAUSE COULD BE ATTRIBUTED TO THE REPORTED EVENTS. .

    Additional Manufacturer Narrative · 0

    THE PROBABLE CAUSE OF THE ISSUE WAS DUE TO A FAULTY FIREFLY FIBER OPTIC CABLE ON THE COMMON COMPUTE CONTROLLER (CCC) BOARD ON THE ROBOT

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH AN INTUITIVE PRODUCT. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE WAY THINGS WORKED WAS WE NOTICED THE DAMAGE TO THE CONSOLE, REPLACED A HANDFUL OF PARTS, AND FROM WHAT I CAN REMEMBER THE SYSTEM STILL WASN'T FIXED AFTERWARDS AS THE ROBOT WASN'T CONNECTING TO THE TOWER, WHICH IS WHY THE FSE MADE THE NOTE SO PEOPLE KNEW WHY WE WERE THERE IN THE FIRST PLACE FOR THE OTHER TWO WORK ORDERS, IF THAT MAKES SENSE. WE COULDN'T GET CONNECTIVITY AND THERE WAS SOME DEBATE ON WHETHER THIS WAS RELATED TO THE TOWER CCC OR THE ROBOT CCC, BUT THE FSE HAD A TOWER CCC IN MY CAR, SO WE DECIDED TO SWAP THAT TO SEE IF THE ERROR WAS RESOLVED. THIS DID NOT FIX THE ERROR, SO WE HAD TO HAVE A CCC FOR THE ROBOT PICKED UP AND RETURNED TO HANCOCK TO BE REPLACED. AFTER THAT WAS REPLACED, THE SYSTEM BOOTED UP AND WAS TESTED AS EXPECTED, SO I THINK IT WAS JUST A VERY ODD COINCIDENCE THAT THE DAMAGE TO THE CONSOLE WASN'T CAUSING CONNECTION ISSUES, AND THAT THE ROBOT CCC ALSO NEEDED TO BE REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216017 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.