BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21981155 · Received May 7, 2025

    Report

    Report Number
    2955842-2025-19692
    Event Type
    Malfunction
    Date Received
    May 7, 2025
    Report Date
    April 10, 2025
    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
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE INTEGRATED ELECTRO SURGICAL GENERATOR UNIT (IESU) TO RESOLVE THE 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 IESU WAS ANALYZED BUT THE REPORTED FAILURE (BIPOLAR WORKING INTERMITTENTLY) COULD NOT BE REPRODUCED ON ERBE CONNECTED TO SYSTEM. LOGS COULD NOT CONFIRM THE FAULT OCCURRED IN THE FIELD. VISUAL INSPECTION: (CRACK ON BEZEL TOP LEFT CORNER AND DENT RIGHT TOP CORNER.) THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM AND FUNCTIONED AS EXPECTED. FAILURE ANALYSIS CONCLUDED THAT NO ROOT CAUSE COULD BE ATTRIBUTED TO THIS ISSUE. THE COMPLAINT WAS CONFIRMED BASED ON THE FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO ELECTRICAL DEFECT OF THE IESU.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INTEGRATED ELECTRO SURGICAL GENERATOR UNIT (IESU) BIPOLAR WAS WORKING INTERMITTENTLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2049410 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-26 N/A 00886874110898

    Patients

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