BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18724246 · Received February 16, 2024

    Report

    Report Number
    2955842-2024-11533
    Event Type
    Malfunction
    Date Received
    February 16, 2024
    Date of Event
    January 25, 2024
    Report Date
    January 25, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. THE FSE REPLACED THE REDUNDANT POWER TRAY ASSEMBLY TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE REDUNDANT POWER TRAY ASSEMBLY TO PERFORM FAILURE ANALYSIS. THE REDUNDANT POWER TRAY ASSEMBLY WAS ANALYZED AND FOUND TO HAVE A POWER DISTRIBUTION BOARD ADC FAULT. THERE WAS AN ANALOG TO DIGITAL CONVERTER VOLTAGE OUT-OF-RANGE ON CHANNEL 9, 12.0V. THIS CORE REDUNDANT POWER TRAY ASSEMBLY WAS TESTED, PROGRAMMED AND SYSTEM STARTED AT NORMAL MODE WITH ERROR 86 TRIGGERED AT STARTUP. THE UNIT WAS IN GOOD PHYSICAL CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO STARTING A BILATERAL INGUINAL HERNIA DA VINCI-ASSISTED PROCEDURE, THE CUSTOMER ENCOUNTERED NON-RECOVERABLE ERROR 86 AFTER THE SYSTEM'S SOFTWARE UPGRADE. PRIOR TO CONTACTING AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE), THE CUSTOMER HARD POWER CYCLED THE SYSTEM. THE SYSTEM POWERED ON NORMALLY, AND THE ERROR 86 RETURNED AFTER APPROXIMATELY 5 MINUTES. THE TSE REVIEWED THE SYSTEM LOGS AND CONFIRMED ERROR 86 POINTING TO A VOLTAGE ERROR ON THE INTUITIVE SURGICAL CORE POWER DISTRIBUTION (IPD). THE CUSTOMER WAS NOT COMFORTABLE STARTING THE PROCEDURE ROBOTICALLY WITH THE PATIENT ASLEEP IN THE OPERATING ROOM. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529049 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-38 N/A

    Patients

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