BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24691860 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-17917
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    March 12, 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
    CA, 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. THE FSE WAS ABLE TO REPRODUCE THE REPORTED ISSUE. THE FSE REPLACED COMMON COMPUTER CONTROLLER (CCC) AS PER ISI PROCEDURE. ISI DID RECEIVE THE CCC AND PERFORMED FAILURE ANALYSIS. DURING FAILURE ANALYSIS, THE CCC WAS VISUALLY INSPECTED, WHERE NO ISSUES WERE FOUND. UNIT WAS INSTALLED ON THE KNOWN GOOD IN-HOUSE SYSTEM AND THE VISION SIDE CART (VSC) MONITOR COULD NOT SHOW FULL DISPLAY ON THE SCREEN. THE VSC TOUCH DISPLAY SHOWED "INSUFFLATOR DISABLED" MESSAGE. THE VSC COULD NOT COMPLETE POWER ON SEQUENCE AND POWER BUTTON KEPT FLASHING BLUE. THE UNIT WAS TAKEN TO A PROGRAMMING STATION WHERE IT WAS CONFIRMED TO BE BRICKED. THE SYSTEM HAS BEEN VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION, 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, THE CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED THAT THE BOOM WAS NOT COMMUNICATING WITH THE TOWER. PRIOR TO CALLING IN THE SITE REBOOTED THE SYSTEM SEVERAL TIMES WITH NO CHANGE. THE TSE HAD SITE PERFORM HARD REBOOT WITH NO CHANGE. THE CALLER STATED THAT THEY HAD A SELF-TEST IN PROGRESS MESSAGE. THE TSE HAD CALLER START THE PATIENT SIDE CART (PSC) IN STANDALONE MODE AND THE PSC POWERED UP NORMALLY. THE VISION SIDE CART (VSC) FAILED TO POWER ON PROPERLY AND THE POWER BUTTON WAS FLASHING BLUE WITH AN INSUFFLATOR ERROR. THE CALLER WAS NOT GIVEN THE OPTION TO DISABLE THE INSUFFLATOR. THE TSE HAD SITE CHANGE GAS TANKS WITH NO CHANGE. THE TSE HAD SITE REMOVE GAS TANKS WITH NO CHANGE. THE SITE WAS NOT GIVEN THE OPTION TO DISABLE THE INSUFFLATOR, AND THE POWER BUTTON WAS FLASHING BLUE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556476 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.