BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19417284 · Received May 29, 2024

    Report

    Report Number
    2955842-2024-15147
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Date of Event
    May 1, 2024
    Report Date
    May 1, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. FSE REPLACED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE IESU INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE IESU SCREEN WENT BLACK DURING USE. IESU DID NOT POWER ON AND THEREFORE FAILURE ANALYSIS WAS UNABLE TO BE PERFORMED. UPON VISUAL INSPECTION, THE TOP COVER HAD A FEW SCRATCHES ON THE BOTTOM LEFT. ALSO, TOP COVER WAS NOT ASSEMBLED CORRECTLY AS THE BACK PART OF TOP COVER WAS STICKING OUT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHROURETERECTOMY SURGICAL PROCEDURE, SITE CONTACTED TECHNICAL SUPPORT ENGINEER (TSE) AND STATED THAT THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) SCREEN WENT BLACK DURING USE. TSE HAD SITE POWER CYCLE THE IESU¿S AND MOVE THE POWER SOURCE TO ANOTHER OUTLET TO CONFIRM A GOOD POWER CONNECTION, BUT THE ISSUE PERSISTED. TSE ASKED IF SITE HAD A THIRD-PARTY GENERATOR AVAILABLE, AND THEY WERE UNSURE BUT AGREED TO CHECK AFTER THE PROCEDURE. TSE REVIEWED THE SYSTEM LOGS AND FOUND NO ASSOCIATED LOGS TO REPORT. SITE INFORMED TSE THAT THE SURGEON WAS ABLE TO PROCEED USING A HARMONIC ACE INSTRUMENT AND CONTINUED WITH THE PROCEDURE AS PLANNED. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF PATIENT HARM DUE TO THIS EVENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PORTS WERE ALREADY PLACED, AND THE SURGERY WAS IN PROGRESS WHEN ISSUE OCCURRED. THE SYSTEM INITIALLY POWERED ON WITHOUT FAULT OR ERRORS. ALL THE CORDS WERE CONNECTED APPROPRIATELY, AND EVERYTHING FUNCTIONED PROPERLY. THE BACKUP GENERATOR COULD NOT BE OBTAINED DURING THE CASE; THEREFORE, THE SURGEON PROCEEDED WITHOUT IT, AND USED A HARMONIC DEVICE. THE ERBE WAS REPLACED AFTER THE CASE HAD ENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1883915 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-44 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES