BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17028294 · Received May 30, 2023

    Report

    Report Number
    2955842-2023-15219
    Event Type
    Malfunction
    Date Received
    May 30, 2023
    Date of Event
    June 14, 2021
    Report Date
    June 14, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    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 COMPLAINT. THE FSE REPLACED THE MASTER TOOL MANIPULATOR (MTM) AND THE REMOTE ARM CONTROLLER (RAC) TO RESOLVE THE ERRORS ISSUE. FOLLOWING THE SERVICE, THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MASTER TOOL MANIPULATOR (MTM) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION COULD NOT REPLICATE THE CUSTOMER REPORTED COMPLAINT. THE MTM2 WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED FAILURE (ERROR 41014) WAS UNABLE TO BE REPRODUCED BUT COULD BE CONFIRMED AS HAVING OCCURRED VIA FIELD ERROR LOGS. THIS ERROR DOES NOT APPEAR TO BE RELATED TO THIS MTM. THERE WERE ALSO ERRORS 23, 30, 23025, 23027, 2303 AND 23031. VISUAL INSPECTION WAS PERFORMED. SINE CYCLE WAS PERFORMED WITHOUT ANY ISSUES. TESTS PERFORMED VIA MATLAB PASSED. HOWEVER, AS A PRECAUTION, THE FOLLOWING PARTS WILL BE REPLACED: THE EMBEDDED SERIALIZE FOR MASTER BASE (ESMB) PRINTED CIRCUIT ASSEMBLY (PCA), AND THE MAIN WIRE HARNESS. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE REMOTE ARM CONTROLLER (RAC) ASSOCIATED WITH THIS COMPLAINT AND COMPLETED ITS INVESTIGATION. FAILURE ANALYSIS INVESTIGATION DID NOT CONFIRM/REPLICATE THE REPORTED COMPLAINT ON THE RAC BOARD. THE BOARD WAS INSTALLED INTO THE TEST SYSTEM AND TESTED WITH MULTIPLE POWER CYCLES WITHOUT TRIGGERING ANY ERRORS DURING TESTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNSPECIFIED UROLOGY SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED MULTIPLE NON-RECOVERABLE ERRORS 41014, 40068 AND 40241. THE CUSTOMER PERFORMED A HARD POWER CYCLE ON THE SYSTEM AND RESEATED ALL BLUE FIBER CABLES WITH NO SUCCESS. THE CUSTOMER ELECTED TO USE ANOTHER DA VINCI SYSTEM. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION. THE PROCEDURE WAS COMPLETED ROBOTICALLY USING ANOTHER DA VINCI SYSTEM WITH NO INJURY TO THE PATIENT. NO PATIENT RELATED INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296560 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

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