BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20511371 · Received October 22, 2024

    Report

    Report Number
    2955842-2024-20855
    Event Type
    Malfunction
    Date Received
    October 22, 2024
    Date of Event
    September 26, 2024
    Report Date
    September 26, 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
    UK
    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 REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) TO RESOLVE THE C-34 ERROR. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE THE IESU INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY (WITH ILEAL CONDUIT) SURGICAL PROCEDURE, THE SYSTEM TRIGGERED A C-34 ERROR POINTING TO THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) CONFIRMED THE ERROR ON THE SYSTEM LOGS ALONG WITH ERRORS M-11, C-30, AND C-38. THE TSE GUIDED THE CUSTOMER THROUGH TROUBLESHOOTING STEPS BUT THE ISSUE PERSISTED. THE CUSTOMER DID NOT HAVE A BACK UP THIRD PARTY GENERATOR OR A SECONDARY VISION SIDE CART (VSC) AVAILABLE. THE TSE SUGGESTED THE CUSTOMER TO USE THE E-100 GENERATOR TO PROCEED WITH THE PROCEDURE. THE PROCEDURE CONTINUED AS PLANNED. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360948 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-24 N/A 00886874110898

    Patients

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