BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16251288 · Received January 26, 2023

    Report

    Report Number
    2955842-2023-10349
    Event Type
    Malfunction
    Date Received
    January 26, 2023
    Date of Event
    December 17, 2022
    Report Date
    January 4, 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
    TN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE SYSTEM EXPERIENCED LEFT EYE ISSUES. BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE SYSTEM EXPERIENCED LEFT EYE ISSUES, 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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. FSE WAS ABLE TO REPRODUCE THE REPORTED ISSUE. THE LEFT EYE HAD A PINK HUE AND THE COLOR BARS HAD ABNORMAL BOX SHAPES IN THEM. FSE SWAPPED LCD INPUT CABLES AND THE ISSUE MOVED TO THE RIGHT EYE, WHICH INDICATES THE POSSIBLE PERSONALITY MODULE SURGEON CONSOLE (PMSC) ISSUE. FSE REPLACED THE PMSC AND THE ISSUE WAS RESOLVED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE PMSC WAS ANALYZED AND FOUND FAILURE ANALYSIS INVESTIGATIONS WAS UNABLE TO REPRODUCE THE REPORTED ISSUE. THE PMSC WAS INSTALLED INTO A IN HOUSE TESTING SYSTEM AND PASSED ALL TESTS. THERE WAS GOOD VIDEO ON BOTH EYES WITH NO ANOMALIES. ADDITIONAL FINDINGS: TWO SURGEON CONSOLE LEAF (SCL) WERE DAMAGED AND NEED TO BE REPLACED. FAILURE ANALYSIS NOTED THAT THE SCL DAMAGE COULD POTENTIALLY CAUSE THE LEFT EYE TO HAVE A PINK HUE. THE PROBABLE ROOT CAUSE OF THE SYSTEM EXPERIENCED LEFT EYE ISSUES CANNOT BE DETERMINED BASED ON THE INFORMATION PROVIDED AND FAILURE ANALYSIS RESULTS. NO PRODUCT ISSUE WAS IDENTIFIED. THE REPORTED EVENT WAS NOT CONFIRMED AS FAILURE ANALYSIS OF PMSC FOUND THEY WERE UNABLE TO REPLICATE THE REPORTED ISSUE. THE PRODUCT WAS VISUALLY INSPECTED AND EVALUATED FOR ITS MECHANICAL AND/OR ELECTRICAL CHARACTERISTICS. THE FAILURE ANALYSIS INVESTIGATIONS AND IN-HOUSE TESTING OF THE RETURNED PRODUCT REVEALED NO ISSUES RELATED TO THE CUSTOMER REPORTED EVENT. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: 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/ABORTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE SYSTEM EXPERIENCED LEFT EYE ISSUES. AS SOON AS THE SURGEON SAT DOWN FOR THE PROCEDURE, THEY NOTICED ISSUES WITH THE LEFT EYE. SITE ATTEMPTED TO POWER CYCLE THE SYSTEM AND TRIED ANOTHER SCOPE, BUT THE ISSUE REMAINED. TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED SYSTEM LOGS AND NOTICED 23 ERRORS FOR POSSIBLE BLUE FIBER. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717291 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-17 N/A 00886874110744

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES