BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20356372 · Received October 2, 2024

    Report

    Report Number
    2955842-2024-20145
    Event Type
    Malfunction
    Date Received
    October 2, 2024
    Date of Event
    September 9, 2024
    Report Date
    September 9, 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
    CA, 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. THE FSE REPLACED THE USM TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE USM INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE USM WAS ANALYZED, AND THE REPORTED FAILURE WAS CONFIRMED AND REPRODUCED. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM AND PASSED IN NORMAL MODE. THE UNIT WAS ALSO TESTED ON A TESTING PLATFORM, AND FIBER TEST FAILED POINTING TO CLOCK SPRING. THE COMPLAINT WAS CONFIRMED BASED ON THE FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PLEURAL DECORTICATION SURGICAL PROCEDURE, A RECOVERABLE ERROR 1162 OCCURRED ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) 2. THE CUSTOMER ATTEMPTED TO POWER CYCLE THE SYSTEM, BUT ISSUE PERSISTED. THE CUSTOMER STATED THAT THEY DISABLED USM 2 AND WAS CONTINUING THE PROCEDURE WITH 3 USMS. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THE LOGS AND CONFIRMED ERROR 1162 POINTING TO USM 2 AXES CONTROLLER SPAR (ACS) BOARD. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017375 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-48 N/A 00886874110720

    Patients

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