BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 17941275 · Received October 16, 2023

    Report

    Report Number
    2955842-2023-19230
    Event Type
    Injury
    Date Received
    October 16, 2023
    Date of Event
    July 17, 2023
    Report Date
    July 17, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. A HARD POWER CYCLE, AND RESEATING BLUE FIBER CABLES AND THE DIGITAL VIDEO INTERFACE (DVI) CABLE DID NOT RESOLVE THE ISSUE. THE FSE REPLACED THE HIGH RESOLUTION STEREO VIEWER (HRSV) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE HRSV INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE MONITOR WAS INSTALLED ON THE TEST SYSTEM. UPON POWER UP, THE SYSTEM BOOTED UP WITH NO ISSUES, EXCEPT THE RIGHT EYE MONITOR WAS DEAD. NO IMAGES WERE BEING SHOWN ON THE RIGHT EYE OF THE SURGEON SIDE CONSOLE (SSC). .

    Description of Event or Problem · 0

    IT WAS INITIALLY REPORTED THAT PRIOR TO THE START (BEFORE PORT PLACEMENT) OF A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITHOUT LYMPHADENECTOMY PROCEDURE, THERE WAS LOSS OF VISION ON THE RIGHT EYE OF THE SURGEON SIDE CONSOLE (SSC). THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) SPOKE TO THE USER TO TROUBLESHOOT THE ISSUE, BUT THE ISSUE COULD NOT BE RESOLVED. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. ON 07-SEP-2023, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION: PORTS WERE PLACED, AND THE SURGEON DISCOVERED THE ISSUE ONCE HE SAT DOWN ON THE SURGEON CONSOLE. THE DELAY TO THE PROCEDURE WAS APPROXIMATELY 5 HOURS, AND THE PATIENT WAS CLOSED AND BROUGHT BACK TO THE THEATRE ONCE THE ISSUE WAS RESOLVED. THE PATIENT WENT TO THE INTENSIVE CARE UNIT (ICU) AFTER THE COMPLETION OF THE SURGERY. ON 10-SEP-2023, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FURTHER INFORMATION: THE DISTRIBUTOR WAS AWARE ON THE PROCEDURE DATE (B)(6) 2023 OF THE ISSUE BEING DISCOVERED WHILST THE PATIENT WAS ON THE TABLE AND THAT THE PORTS WERE PLACED. THEY WERE INFORMED ON (B)(6)2023 OF THE PATIENT BEING SENT TO ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705015 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-23 N/A 00886874110744

    Patients

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