BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20218109 · Received September 13, 2024

    Report

    Report Number
    2955842-2024-19301
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    August 22, 2024
    Report Date
    August 22, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110898
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE REDUNDANT POWER TRAY ASSEMBLY TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS AND THE REPORTED FAILURE WAS REPLICATED. THIS POWER TRAY WAS INSTALLING INTO THE TEST SYSTEM, AND IT FAILED ERROR 86 AFTER 10X POWER CYCLES, IT REPLICATED FAILURE REPORT. INSTALLED NEW IPD PCA RETESTED POWER CYCLE 10X NO ERROR. THE UNIT DISPLAYED GOOD CONDITION. THE COMPLAINT WAS CONFIRMED BASED ON THE FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, CUSTOMER HAS EXPERIENCED THREE NON-RECOVERABLE FAULTS. THE CUSTOMER HAD POWER CYCLED THE SYSTEM AFTER EACH NON RECOVERABLE FAULT BUT THE ISSUE REMAINED. THE TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS AND CONFIRMED THE ISSUE. TSE WALKED CALLER THROUGH A HARD POWER CYCLE OF THE TOWER BUT THE ISSUE REMAINED. THE CUSTOMER CONFIRMED THEY DID HAVE ANOTHER TOWER AVAILABLE AND TSE ADVISED TO SWAP TOWERS. THE PROCEDURE WAS CONVERTED TO ANOTHER DV SYSTEM WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113190 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-31 N/A 00886874110898

    Patients

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