BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 25155200 · Received May 12, 2026

    Report

    Report Number
    2955842-2026-24821
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 12, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    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 GENERATOR UNIT TO RESOLVE THE CUSTOMER REPORTED ISSUE. 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 UNIT WAS ANALYZED, AND THE REPORTED PROBLEM COULD NOT BE CONFIRMED THROUGH SYSTEM LOGS. VISUAL INSPECTION REVEALED SLIGHT DISCOLORATION ON THE HEATSINK. DURING FUNCTIONAL TESTING, AN ISSUE WAS IDENTIFIED WHEREIN MONOPOLAR CONNECTOR #1 DID NOT DETECT OR RECOGNIZE THE INSTRUMENT. THE LOG RECORDED ERRORS M-37, M-0B, M-B0, AND M-1F. THE COMPLAINT WAS CONFIRMED BASED ON THE FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF CUSTOMER REPORTED ISSUES IS ATTRIBUTED TO FAULTY ELECTRICAL COMPONENTS INSIDE THE GENERATOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BIPOLAR PORTS DID NOT DETECT THE INSTRUMENTS. IT WAS NOT RECOGNIZING INSTRUMENTS IN ANY OF THE 4 PORTS. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226381 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-33 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1