BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 22189363 · Received June 11, 2025

    Report

    Report Number
    2955842-2025-24466
    Event Type
    Malfunction
    Date Received
    June 11, 2025
    Date of Event
    May 21, 2025
    Report Date
    May 21, 2025
    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
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: H2, H3, ANNEX CODES C, D. INTUITIVE SURGICAL, INC. RECEIVED THE MASTER TOOL MANIPULATOR (MTM) TO PERFORM FAILURE ANALYSIS HOWEVER, THE CUSTOMER'S REPORTED EVENT COULD NOT BE REPLICATED. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT.

    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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. THE FSE REPLACED THE MTM ON THE SURGEON SIDE CONSOLE 2 (SSC2) TO RESOLVE THE CUSTOMERS REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE MASTER TOOL MANIPULATOR (MTM) PRODUCT HAS BEEN RECEIVED; HOWEVER, FAILURE ANALYSIS HAS NOT BEEN COMPLETED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT UNIVERSAL SURGICAL MANIPULATOR (USM) 3 STOPPED WORKING. THE CUSTOMER RESTARTED THE SYSTEM AND WAS OBSERVING ERRORS POINTING TO THE RIGHT MASTER TOOL MANIPULATOR (MTM) ON THE SECOND SURGEON SIDE CONSOLE (SSC). TECHNICAL SERVICE ENGINEERING (TSE) CONFIRMED THE ERROR. THE PROCEDURE WAS CONTINUED ON A SECONDARY SSC WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103540 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-29 N/A 00886874110744

    Patients

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