BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17057430 · Received June 5, 2023

    Report

    Report Number
    2955842-2023-14322
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Date of Event
    January 7, 2021
    Report Date
    January 7, 2021
    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
    IN, 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 COMPLAINT. THE FSE REPLACED THE SYSTEM¿S UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE USM INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED AND REPRODUCED THE REPORTED FAILURE, ERROR 23094. THE USM WAS TESTED ON AN IN-HOUSE SYSTEM AND FAILED NORMAL MODE AS IT TRIGGERED ERROR 23069. A REVIEW OF THE REMOTEFE LOGS SHOWED ERRORS: 23094, 23069, AND 23118 ON AXIS 3. WHEN THE INSERTION CHIPENCODER VIRTUAL ABSOLUTE (CVA) PRINTED CIRCUIT ASSEMBLY (PCA) AND FLAT FLEX CABLE (FFC) WERE REPLACED WITH GOLD PARTS, THE ERROR 23069 WENT AWAY. WHEN THE ORIGINAL CVA CPA AND FFC WERE RE-INSTALLED, THE ERROR 23069 CAME BACK. THE UNIT WENT THROUGH MORE TESTING ON A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP), USING THE GOLD PARTS, IT PASSED THE LISSAJOUS, CHIPENCODER VIRTUAL ABSOLUTE (CVA) CHARACTERIZATION, CARRIAGE STRENGTH, FRICTION TESTS, CARRIAGE SENSORS CHECK, CARRIAGE FRICTION AND ADVANCED BRAKE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYSTEM HAD AN ERROR 23094 ON THE SYSTEMS UNIVERSAL SURGICAL MANIPULATOR (USM) 3. THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) TRIED TO RECOVER THE FAULT MULTIPLE TIMES AND HARD POWER-CYCLED THE SYSTEM WITH NO CHANGE. THE CSR REPORTED THAT THE SURGEON CHOSE TO DISABLE THE USM 3 AND CONTINUE THE PROCEDURE USING ONLY THREE (3) USMS. AN ISI TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE SYSTEM ERROR LOGS AND NOTICED MULTIPLE ERROR 23094 REPORTED BY THE USM 3, AXIS 3 (INSERTION AXIS). THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED PATIENT HARM, INJURY, OR ADVERSE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1449744 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-49 N/A 00886874110720

    Patients

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