BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20348733 · Received October 1, 2024

    Report

    Report Number
    2955842-2024-19944
    Event Type
    Malfunction
    Date Received
    October 1, 2024
    Date of Event
    September 5, 2024
    Report Date
    September 5, 2024
    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
    IT
    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. FSE REPLACED ARMREST LIMIT SWITCH TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HIGH RESOLUTION STEREO VIEWER (HRSV) AND ARMREST LOCKED. THE TECHNICAL SUPPORT ENGINEER (TSE) ASKED TO THE CUSTOMER TO REBOOT THE SYSTEM, BUT THE ISSUE REOCCURRED. TSE ASKED IF USING THE SWITCH PANEL THEY HEAR THE MOTORS TURNING, THEY ANSWERED NO. THE PROCEDURE WAS CONVERTED TO ANOTHER SURGEON SIDE CONSOLE (SSC) WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2007027 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-24 N/A 00886874110744

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES