BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 23494210 · Received November 7, 2025

    Report

    Report Number
    2955842-2025-44325
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    October 27, 2025
    Report Date
    December 12, 2025
    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
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. IN THE SYSTEM LOGS ERRORS 31089, 31030, 307 & 48308 WERE FOUND INDICATING THAT THESE FAULTS HAD OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE CONSOLE COMMON COMPUTE CONTROLLER (CCC) WAS INSTALLED, PROGRAMMED AND TESTED ON THE DA VINCI 5 IN HOUSE GOLDEN SYSTEM WITH NO ISSUE AND NO ERRORS TRIGGERED AT STARTUP, SYSTEM STARTED AT NORMAL AS EXPECTED. RAN MULTIPLE MANUAL POWER CYCLES WITH NO ISSUE. THIS UNIT WAS LEFT IDLING OVER THE WEEKEND IN NORMAL MODE WITH NO ISSUE AND NO FAILURE TRIGGERED. AFTER CHECKING THE LIGHT LEVEL, ALL CHANNELS ARE WELL WITHIN NORMAL RANGE. THE EVENT WAS CONFIRMED BASED ON ERROR LOG REVIEW, HOWEVER THE ISSUE WAS NOT ABLE TO BE REPLICATED DURING IN-HOUSE TESTING. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE CCC BOARD FROM THE TOWER WAS ANALYZED AND FOUND TO NOT BE PROGRAMMABLE WHEN INSTALLED ON AN IN-HOUSE SYSTEM. THE FIBER OPTIC CABLE ASSEMBLY ON THE CCC BOARD WAS CONFIRMED TO BE THE SOURCE OF THE ISSUE AND THE CCC BOARD WAS PROGRAMMED WITH A NEW CABLE. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE CAUSE OF THE ISSUE WAS DUE TO A FAULTY FIBER OPTIC CABLE ON THE CCC BOARD ON THE TOWER.

    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. THE FSE VERIFIED THAT THE SECOND CONSOLE WAS NOT CONNECTING TO THE SYSTEM. THE BLUE LIGHT ON THE BOTTOM LEFT FIBER PORT ON THE BACK OF THE TOWER WAS NOT ON. THE FSE REPLACED THE TOWER COMMON COMPUTE CONTROLLER (CCC). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A REOCCURRING ISSUE WITH THE CONSOLE NOT BEING CONNECTED. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CLINICAL TERRITORY ASSOCIATE (CTA) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTED ISSUE OCCURRED DURING PROCEDURE. AFTER SWITCHING FROM A DUAL-CONSOLE TO A SINGLE-CONSOLE CONFIGURATION, THE PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT ANY INJURY OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1860690 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