BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 18373130 · Received December 21, 2023

    Report

    Report Number
    2955842-2023-21606
    Event Type
    Injury
    Date Received
    December 21, 2023
    Date of Event
    December 2, 2023
    Report Date
    December 2, 2023
    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
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE SURGEON CONVERTED THE PROCEDURE TO OPEN SURGERY DUE TO ISSUES WITH REPEATED UNRECOVERABLE FAULTS. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS ABLE TO REPRODUCE THE ISSUE AND REPLACED THE REDUNDANT POWER TRAY ASSEMBLY. THE SYSTEM WAS TESTED AND WAS READY FOR USE. ISI DID RECEIVE THE REDUNDANT POWER TRAY ASSEMBLY TO PERFORM FAILURE ANALYSIS (FA). FA WAS ABLE TO CONFIRM AND REPRODUCE THE CUSTOMER REPORTED COMPLAINT. THIS REDUNDANT POWER TRAY ASSEMBLY WAS TESTED ON AN IN-HOUSE SYSTEM. THE PROGRAM AND SYSTEM STARTED AT NORMAL MODE WITH NO ERROR TRIGGERING AT START UP. RAN 10 POWER CYCLES AND IT PASSED, HOWEVER, DURING IDLE TEST, ERROR 86 WAS TRIGGERED AFTER 15 MINUTES. CHECKING ON SYSTEM LOGS THE ADC VOLTAGE VALUE WAS SLIGHTLY BELOW THE MINIMUM RANGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DIAPHRAGMATIC HERNIA REPAIR SURGICAL PROCEDURE THAT AN UNRECOVERABLE FAULT OCCURRED. PRIOR TO CALLING, THE CALLER POWER CYCLED THE SYSTEM WITH NO CHANGE. ERROR 86 WAS OBSERVED IN THE LOGS. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WALKED THE CALLER THROUGH A HARD POWER CYCLE OF THE VISION SIDE CART (VSC) AND THE ERROR DID NOT PERSIST. THE CUSTOMER CONTACTED THE TSE AGAIN AFTER THE PROCEDURE AND STATED THAT THE ERROR OCCURRED AGAIN, AND ANOTHER POWER CYCLE WAS PERFORMED, BUT THE ERROR PERSISTED. THE SURGEON ELECTED TO CONVERT THE PROCEDURE TO OPEN SURGERY DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304543 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-45 N/A 00886874110898

    Patients

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