BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 18636954 · Received February 2, 2024

    Report

    Report Number
    2955842-2024-10708
    Event Type
    Injury
    Date Received
    February 2, 2024
    Date of Event
    January 10, 2024
    Report Date
    January 10, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 REPLACED THE ON/OFF BREAKER, AC FILTER, ISOLATION TRANSFORMER AND THE CORE POWER TRAY ASSEMBLY. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO HAVE THE ISI DEVICES RETURNED; HOWEVER, ISI HAS NOT RECEIVED THE DEVICES FOR FAILURE ANALYSIS INVESTIGATIONS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE REDUNDANT MEDICAL GRADE POWER SUPPLY (RMGPS) WAS ANALYZED AND FOUND TO HAVE NO FAILURES OR ERRORS. THE RMGPS WAS INSTALLED ON THE SYSTEM IN NORMAL MODE AND HAD NO SHUTDOWN FAILURES. THE 12V OUTPUT OF BOTH POWER SUPPLIES WERE ACCEPTABLE. HOWEVER, ERROR 1102 WAS TRIGGERED DURING THE POWER CYCLE TESTING. THE DRAWER FANS WILL BE REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED PROCEDURE, POST-ANESTHESIA AND PORT PLACEMENT, THE VISION SIDE CART (VSC) POWERED OFF. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY. TECHNICAL SUPPORT WAS CALLED AFTER CONVERTING THE PROCEDURE, AND THE TECHNICAL SUPPORT ENGINEER (TSE) ASKED THE SITE TO REBOOT THE SYSTEM, TRY TO CHANGE THE AC WALL PLUG, AND RESET THE BREAKER ON THE VSC, BUT THE ISSUE PERSISTED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1572674 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-45 N/A 00886874110898

    Patients

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