BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24693704 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-18410
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    July 1, 2024
    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
    FL, 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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. FSE WAS ABLE TO REPLICATE THE REPORTED ISSUE. FSE REPLACED THE MACHINE LEARNING XAVIER (MLX) AND COMMON COMPUTE CONTROLLER (CCC) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE PN: 658890-21 MLX UNIT WAS RETURNED FOR EVALUATION, AND THE REPORTED "ERROR 40096" WAS CONFIRMED AND REPLICATED. THE UNIT WAS INSTALLED ON AN IN-HOUSE EFT SYSTEM, PROGRAMMED TO CUSTOMER SOFTWARE A80_P1.1.1_B462 (WJ79), AND POWERED UP IN NORMAL MODE WITH ERROR 40096 PRESENT ON THE TOWER DISPLAY. THE PN: 656810-21 CCC UNIT WAS PLACED ON PCA CONFIGURATION EFT 722735-01 AND TESTED PER IPC 1069151-01 TO CONFIRM THE REPORTED PROBLEM SHOWING SYMPTOMS OF A "BRICKED" TEGRA MODULE. THE PROBLEM WAS CONFIRMED PER THE IPC INSTRUCTIONS. THE RECOMMENDATION FOR REPAIR IS TO REPROGRAM IT ACCORDING TO THE IPC INSTRUCTIONS. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) RECEIVED ERROR 40096 AND EMERGENCY POWER OFF WITH NO CHANGE. THE CUSTOMER HAS ANOTHER SYSTEM AND WANTS TO SWAP THE CASE TO THAT SYSTEM AND STOP TROUBLESHOOTING. THE ERROR MOST LIKELY IS A HARD ERROR. THE PROCEDURE WAS ABORTED TO ANOTHER DV SYSTEM WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477275 DAVINCI 5 PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380747-40 N/A 00886874119716

    Patients

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