BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16912549 · Received May 11, 2023

    Report

    Report Number
    2955842-2023-13020
    Event Type
    Malfunction
    Date Received
    May 11, 2023
    Date of Event
    April 17, 2023
    Report Date
    April 17, 2023
    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
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING BLACK LEFT EYE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. 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 HRSV TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE HRSV WAS ANALYZED AND FAILURE ANALYSIS (FA) REPLICATED THE CUSTOMER REPORTED COMPLAINT. IN-HOUSE FA INSTALLED AND TESTED THE HRSV MONITOR IN THE PCA SI SYSTEM, THE SYSTEM STARTED UP AND FAILED WITHOUT VIDEO ON THE DISPLAY. THIS COMPLAINT IS REPORTABLE MALFUNCTION EVENT DUE TO THE FOLLOWING CONCLUSION: THE CUSTOMER CONVERTED TO LAPAROSCOPY AFTER THE START OF THE PROCEDURE DUE TO THE SURGEON HAD NO VIEW OUT OF THE LEFT EYE. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, SYSTEM UNAVAILABILITY AFTER THE START OF A SURGICAL PROCEDURE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR AS IT MAY LEAD TO AN INJURY DUE TO THE PATIENT¿S INABILITY TO TOLERATE A CONVERSION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY SURGICAL PROCEDURE, THE LEFT EYE ON THE SURGEON CONSOLE IS BLACK. THE LEFT EYE ON TSC IS WORKING PROPERLY. THE SYSTEM IS NOT CONNECTED TO ONSITE. ALSO, THERE WERE NO ICONS IN THE LEFT HIGH RESOLUTION STEREO VIEWER (HRSV). AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) GUIDED THE SURGEON TO HARD POWER CYCLE THE SURGEON SIDE CART (SSC). THE PROCEDURE WAS CONVERTED TO LAPAROSCOPY WITH NO REPORTS OF PATIENT INJURY. ISI HAS MADE SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER CONCERNING THE REPORTED EVENT WITH NO SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842844 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-04 N/A 00886874110744

    Patients

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