BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20023914 · Received August 22, 2024

    Report

    Report Number
    2955842-2024-18094
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 24, 2024
    Report Date
    July 24, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE
    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. THE FSE CONFIRMED ERROR 31094 WAS PRESENT AFTER THE SYSTEM REBOOT. FSE FOUND THAT THE PATIENT SIDE CART (PSC) WAS STUCK AT THE MAX HEIGHT. FSE REPLACED THE UNIVERSAL (UNIT) CONTROLLER CARD (UCC). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE DA VINCI PRODUCTS INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE UCC WAS ANALYZED, AND THE FAILURE WAS REPLICATED AND CONFIRMED. THIS UCC CFG UNIT WAS INSTALLED AND TESTED ON NORMAL MODE AND PROGRAMMED ON THE FINAL TEST SYSTEM, AND THE SYSTEM TRIGGERED ERROR 31094 AT STARTUP. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION AND FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MITRAL VALVE REPAIR SURGICAL PROCEDURE, THE SYSTEM WOULD NOT RECOGNIZE THE MONOPOLAR INSTRUMENTS AND STATED THE INSTRUMENT NOT SUPPORTED. THE CUSTOMER TRIED SEVERAL MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENTS FROM DIFFERENT LOT #'S WITH NO CHANGE. THE CUSTOMER MOVED THE INSTRUMENT TO OTHER UNIVERSAL SURGICAL MANIPULATORS WITH NO CHANGE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOUND MULTIPLE INF CEILING MOUNT CONTROLLER (CMC) ERRORS IN THE LOGS. THE TSE ADVISED THE CUSTOMER TO PERFORM AN EMERGENCY-STOP OR A HARD POWER CYCLE. THE SURGEON OPTED TO POWER CYCLE THE SYSTEM. AFTER POWER CYCLING THE SYSTEM, THE ERROR 31094 RETURNED AS A NON-RECOVERABLE POINTING TO THE PAC. THE PROCEDURE WAS CONVERTED TO ANOTHER DA VINCI SYSTEM WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013829 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-53 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES