BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 23458829 · Received November 3, 2025

    Report

    Report Number
    2955842-2025-43726
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Date of Event
    October 13, 2025
    Report Date
    November 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
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROBABLE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. SINCE THE PRODUCT WAS NOT RETURNED, THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED OR REPLICATED. THIS ISSUE CAN BE RESOLVED BY USING AN ALTERNATE INSTRUMENT TO COMPLETE THE PROCEDURE.

    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 REPROGRAMMED THE SYSTEM TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A LOSS OF POWER IN THE OPERATING ROOM, THE SYSTEM EXPERIENCED NON-RECOVERABLE ERRORS. THE TECHNICAL SUPPORT ENGINEER WAS CONTACTED TO TROUBLESHOOT THE ISSUE. UPON ATTEMPTING TO POWER UP THE SYSTEM AFTER THE LOSS OF AC POWER, THE SYSTEM FAULTED, AND THE TOWER DISPLAY REMAINED BLANK. IT WAS RECOMMENDED TO POWER OFF AND RESET THE TOWER BREAKER. ALTHOUGH THE SYSTEM POWERED ON, IT CONTINUED TO SHOW NON-RECOVERABLE ERRORS. SYSTEM LOGS INDICATED THAT THE TOWER'S COMMON COMPUTE COMPUTER (CCC) HAD REVERTED TO A GOLDEN IMAGE OF A NON-CLINICAL SOFTWARE VERSION. CONSEQUENTLY, THE CUSTOMER CONVERTED THE PROCEDURE TO CONTINUE NON-ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: NO ADDITIONAL PORTS WERE ADDED. NO PORTS WERE EXPANDED. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053071 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.