BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19563981 · Received June 18, 2024

    Report

    Report Number
    2955842-2024-15706
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    May 21, 2024
    Report Date
    May 21, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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 THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE DA VINCI PRODUCT INVOLVED IN THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. AT THE TIME OF THIS REPORT, THE FAILURE ANALYSIS HAS NOT BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS (FA). THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS ANALYZED AND THE REPORTED FAILURE WAS CONFIRMED VIA THE ERROR LOGS AND REPLICATED IN-HOUSE. THE SITE'S LOGS SHOWED MULTIPLE 319 ERRORS POINTING TOWARD THE AXES CONTROLLER, CARRIAGE (ACC) AND OTHER COMMUNICATION ERRORS (25730, 32097, AND 40084). THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE WHERE IT TRIGGERED A 319 ERROR POINTING TOWARD THE ACC. THE UNIT WAS ALSO TESTED ON A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE IT FAILED THE CHECK ALL BOARDS PRESENT AND THE FIBER TESTS POINTING TOWARDS THE ROLLING LOOP FIBER. DURING THE INVESTIGATION, IT WAS NOTED THAT THE ROLLING LOOP FIBER AND GROUND STRAPS WERE TANGLED IN THE SPAR.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578109 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-42 N/A 00886874110720

    Patients

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