BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24710118 · Received March 30, 2026

    Report

    Report Number
    2955842-2026-19153
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    September 30, 2025
    Report Date
    March 26, 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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. THE FSE REPLACED THE TOWER COMMON COMPUTE CONTROLLER (CCC) BOARD. 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 TOWER CCC WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED FAILURE WAS REPLICATED AND CONFIRMED. IN THE ERROR LOGS, THE REPORTED ERRORS WERE FOUND INDICATING THAT THEY DID OCCUR IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE TOWER CCC WAS INSTALLED, PROGRAMMED AND TESTED ON AN IN-HOUSE GOLDEN SYSTEM WHERE PROGRAMMING WAS NOT ACHIEVABLE TO PROGRAM. THE TOWER WAS NOT POWERING UP COMPLETELY. THE POWER BUTTON WAS FLASHING BLUE, REPLICATING THE REPORTED FAILURE. THE TOWER CCC WAS BRICKED. TO CONFIRM AND VERIFY THE ROOT CAUSE OF THIS REPORTED FAILURE, THE TOWER CCC UNIT WAS BENCH TESTED AND CONFIRMED TO BE A BRICKED UNIT. THE CCC WAS PROGRAMMED/UNBRICKED AND INSTALLED BACK ONTO THE SYSTEM TO VERIFY THAT THE CCC FUNCTIONED AS DESIGN, WHICH RESULTED IN THE SYSTEM STARTING UP NORMALLY AS EXPECTED. AS A RESULT OF THE TEST AND FINDINGS, FAILURE ANALYSIS WAS ABLE TO CONCLUDE THAT THE TOWER CCC WAS VERIFIED TO BE THE ROOT CAUSE OF THE REPORTED FAILURE. THE BOARD WAS BRICKED/CORRUPTED OR FAILED PROGRAMMING PROCEDURES. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, OPERATING ROOM STAFF CALLED TECHNICAL SUPPORT TO REPORT THAT THE SYSTEM HAD A FAULT AND REQUIRED A RESTART. AFTER RESTARTING, THE SYSTEM DISPLAYED A RECOVERABLE FAULT, WHICH WAS RESOLVED AND THE SYSTEM WAS OPERATING WITHOUT FAULTS. THE SYSTEM THEN FAULTED AGAIN AND WAS RESTARTED. WHILE TECHNICAL SUPPORT ENGINEER (TSE) WAS ON THE PHONE, THE FAULT HAD NOT RETURNED, BUT TSE INFORMED THE CUSTOMER THAT IT COULD RECUR. THE CUSTOMER MENTIONED THAT THERE WAS NO OTHER SYSTEM AVAILABLE IF FURTHER FAULTS OCCURRED. THE REPORTED FAULTS INCLUDED 40068 AND 170. THE DECISION TO PROCEED WITH THE CASE WAS PENDING DISCUSSION WITH THE SURGEON, AND LOGS WERE NOT AVAILABLE AT THE TIME OF THE CALL. THE PROCEDURE WAS ABORTED WITH NO PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS ABORTED PRIOR TO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330619 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-40 N/A 00886874119662

    Patients

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