BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI 5

    MDR report key: 24694686 · Received March 25, 2026

    Report

    Report Number
    2955842-2026-18087
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    February 4, 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
    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 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 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 SURGICAL PROCEDURE, THE TOWER AND ROBOT WERE NOT CONNECTING AT POWER UP. THEY RESET THE BREAKERS, PERFORMED AN EMERGENCY POWER OFF (EPO) ON THE ROBOT, RESEAT THE BLUE CABLE AND THE SYSTEM POWERED ON, BUT DID NOT COMPLETE POWER ON SELF-TEST. THEY UNPLUGGED THE BLUE CABLE AND POWERED ON THE TOWER AND CONSOLE IN STANDALONE MODE AND BOTH POWER ON AND WORK IN STANDALONE MODE. THE TOWER DID NOT POWER ON. THE SYSTEM WAS DOWN. THE PROCEDURE WAS ABORTED WITH NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302035 DAVINCI 5 VISION SIDE CART NAY INTUITIVE SURGICAL, INC 380746-40 N/A 00886874119662

    Patients

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