BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24694379 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-18085
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    August 14, 2025
    Report Date
    March 25, 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
    PA, 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. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE COMMON COMPUTE CONTROLLER (CCC) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THIS UNIT WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED ISSUE WAS CONFIRMED AND REPLICATED. IN REMOTE FE AND ARTEMIS, NO DATA WAS FOUND TO INDICATE THAT THE FAULT HAD OCCURRED IN THE FIELD. VISUAL INSPECTION FOUND NO ISSUES RELATED TO THE EVENT. THE UNIT WAS INSTALLED ONTO A KNOWN GOOD IN-HOUSE SYSTEM, BUT THE SYSTEM COULD NOT POWER ON COMPLETELY. THE POWER BUTTON ON THE TOWER KEPT FLASHING BLUE. THE UNIT WAS TESTED ON THE BENCH PROGRAMMING STATION AND WAS DETERMINED TO BE BRICKED. AS A RESULT OF THESE FINDINGS, FAILURE ANALYSIS CONCLUDED THAT THE ROOT CAUSE OF THE ISSUE IS A BRICKED CCC. UNBRICKING WAS PERFORMED, AND THE UNIT WAS REINSTALLED INTO THE SYSTEM, WHICH THEN POWERED ON NORMALLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYSTEM WOULD NOT POWER UP COMPLETELY, AND THE TOWER POWER BUTTON WAS FLASHING BLUE. THE TECHNICAL SUPPORT ENGINEER (TSE) INSTRUCTED THE CUSTOMER TO BRING ALL COMPONENTS UP IN STANDALONE MODE. THE CONSOLES AND ROBOT POWERED UP NORMALLY, BUT THE TOWER CONTINUED TO HAVE A FLASHING BLUE POWER BUTTON AND DISPLAYED AN "INSUFFLATOR DISABLED" MESSAGE. THE CUSTOMER PLANNED TO CONTACT THE CHARGE NURSE TO DETERMINE THE NEXT STEPS FOR THE CASE DUE TO THE SYSTEM BEING DOWN. THE CUSTOMER MENTIONED THAT STORMS HAD PASSED THROUGH THE AREA THE PREVIOUS NIGHT, BUT IT WAS UNCLEAR IF THERE HAD BEEN ANY POWER ISSUES AT THE HOSPITAL. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150514 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