BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24694682 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-17940
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    January 23, 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
    FL, US
    Reporter Occupation
    003

    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 REPLACED THE COMMON COMPUTE CONTROLLER (CCC). 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 CCC WAS VISUALLY INSPECTED, WHERE NO ISSUES WERE FOUND. THE UNIT WAS TAKEN TO A PROGRAMMING STATION WHERE IT WAS CONFIRMED TO BE BRICKED 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 INGUINAL HERNIA - BILATERAL SURGICAL PROCEDURE, THE LIGHTS ON THE ROBOT WERE NOT COMING ON PRIOR TO START OF CASE. ONSITE WAS NOT REPORTING. THE CALLER INFORMED THAT THE TOWER POWER BUTTON WAS FLASHING BLUE, BUT CONSOLE AND ROBOT POWER BUTTON HAD SOLID BLUE BACKLIGHT. THE TECHNICAL SUPPORT ENGINEER (TSE) WALKED THE CALLER THROUGH POWERING OFF SYSTEM AND DISCONNECTING BLUE FIBER CABLES FROM BACK OF TOWER AND POWERING ON THE TOWER IN STANDALONE MODE. THE TOWER WOULD NOT COMPLETE POST AND POWER BUTTON WAS FLASHING BLUE. IT WAS UNKNOWN HOW THE SITE WOULD PROCEED WITH THE CASE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174734 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