BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22085420 · Received May 27, 2025

    Report

    Report Number
    2955842-2025-22046
    Event Type
    Malfunction
    Date Received
    May 27, 2025
    Date of Event
    April 29, 2025
    Report Date
    April 29, 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
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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 COMPLAINT. THE FSE WAS ABLE TO REPRODUCE THE ISSUE AND REPLACED THE VIO INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE IESU HAS BEEN EVALUATED BY THE FAILURE ANALYSIS (FA) TEAM. FA WAS ABLE TO CONFIRM THE REPORTED COMPLAINT VIA SYSTEM LOGS AND REPRODUCE THE ISSUE DURING IN-HOUSE TESTING. DURING VISUAL INSPECTION, FA FOUND SCRATCHES ON SIDE OF COVER. THE UNIT THAT WAS PLACED ON GOLDEN SYSTEM AND WAS RUN IN NORMAL MODE AND M-02-7 ERRORS APPEARED AT START UP. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO ELECTRICAL AND FIBEROPTIC ISSUES DUE TO MODULE TIMEOUT FAILURE ON THE IESU.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER REPORTED TO INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) THAT THAT THEY WERE GETTING REPEATED M-02 FAULTS ON VIO INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU). THE CUSTOMER POWER CYCLED, AND HARD POWER CYCLED THE IESU, AND THE FAULTS PERSISTED. THE CUSTOMER DID NOT HAVE A SECONDARY VISION SIDE CART (VSC) AVAILABLE AND ONLY AN FT-10 AND WAS MOVING FORWARD USING THE E-100 GENERATOR. THE CUSTOMER CALLED BACK AND STATED THEY SWAPPED TO A BACKUP DA VINCI SYSTEM TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333332 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-41 N/A 00886874110898

    Patients

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