BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21120501 · Received January 9, 2025

    Report

    Report Number
    2955842-2025-00274
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    December 16, 2024
    Report Date
    December 16, 2024
    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
    CH
    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 EVENT. THE FSE RESEATED THE CONNECTOR ON THE HIGH-RESOLUTION STEREO VIEWER (HRSV). THE HRSV DISPLAYED NORMALLY. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE THAT THE SURGEON SIDE CONSOLE'S (SSC) HIGH RESOLUTION STEREO VIEWER (HRSV) HAD NO IMAGE IN THE RIGHT EYE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED HARD POWER CYCLING THE SYSTEM AND RESEATING THE BLUE FIBER CABLE, BUT THE ISSUE REMAINED. THE SITE CONVERTED TO ANOTHER DA VINCI SYSTEM. THERE WERE NO REPORTS OF PATIENT INJURY. ISI RECEIVED THE FOLLOWING ADDITIONAL INFORMATION VIA FOLLOW-UP: THE SYSTEM DID NOT PRESENT ANY FAULTS WHEN INITIALLY POWERED ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364753 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-17 N/A 00886874110744

    Patients

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