BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 25257158 · Received May 22, 2026

    Report

    Report Number
    2955842-2026-26128
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    April 25, 2026
    Report Date
    May 22, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 PERSONALITY MODULE SURGEON CONSOLE (PMSC). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRAINING/DEMO OF THE DA VINCI SYSTEM THERE HAD BEEN NO OUTPUT IMAGE FROM THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) DURING SIMULATOR PRACTICE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529707 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-24 N/A 00886874110744

    Patients

    Seq Age Sex Outcome Treatment
    1