BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20153018 · Received September 5, 2024

    Report

    Report Number
    2955842-2024-19033
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    August 13, 2024
    Report Date
    August 13, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. DURING FIELD EVALUATION, FSE CONFIRMED PMA 54 INDICATING INTERMITTENT REMINDER TO CLEAN THE SYSTEM CABLE CONNECTIONS. AS PART OF SERVICE, FSE REPLACED THE SYSTEM CABLE, TRANSCEIVERS AND COVER. AFTER REPLACEMENT, THE DA VINCI SYSTEM WAS RECALIBRATED, TESTED, OPERATED WITHOUT ERROR AND VERIFIED READY FOR USE. THE AFFECTED PART INVOLVED WITH THIS COMPLAINT IS A FIELD SCRAP ITEM AND WILL NOT BE RETURNED TO ISI FOR FURTHER INVESTIGATION. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UROLOGY PYELOPLASTY SURGICAL PROCEDURE USING A DUAL SURGEON CONSOLE (SSC) SETUP, THE RIGHT MASTER TOOL MANIPULATOR (MTM) ON SSC1 WAS NOT RESPONDING. SURGEON CONTINUED THE CASE USING SSC2 MTM. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THE SYSTEM LOGS AND CONFIRMED A PREVENTIVE MAINTENANCE ADVISORY (PMA) 54 REGARDING POWER WARNING POINTING TO FIBER CABLE CONNECTING TO THE AFFECTED CONSOLE. THERE WAS NO SYSTEM ERROR MESSAGE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE NURSE CONFIRMED NO ISSUE UPON POWER UP. PROCEDURE WAS COMPLETED USING SSC2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1835707 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-04 N/A 00886874110744

    Patients

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