BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20252432 · Received September 18, 2024

    Report

    Report Number
    2955842-2024-19613
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    August 26, 2024
    Report Date
    August 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
    CH
    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 ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE UNIT WAS RETURNED FOR FAILURE ANALYSIS, BUT THE REPORTED ISSUE COULD NOT BE REPRODUCED. THE UNIT ENERGIZED AND CAUTERIZED, AND ALL PORTS RECOGNIZED INSTRUMENTS. THERE WERE NO ERRORS UPON MULTIPLE ACTIVATIONS. HOWEVER, EVERY TIME THE UNIT POWERED ON AND OFF, THE TECHNICIAN SELECTED THE RECALL SETTINGS, AND THEY WERE NOT SAVED. THE RECALL SETTINGS KEPT CHANGING. ADDITIONALLY, BIPOLAR SOCKET #2 FELT LOOSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) BIPOLAR ENERGY HAD NO OUTPUT. THE CUSTOMER STATED THAT THE MONOPOLAR ENERGY WAS NORMAL BUT THE BIPOLAR HAD NO ENERGY. THE CUSTOMER POWER CYCLED THE SYSTEM AND SWAPPED TO ANOTHER ENERGY CABLE, BUT THE ISSUE PERSISTED. THE CUSTOMER SWAPPED TO AN EXTERNAL FORCETRIAD GENERATOR TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: ERROR 25920 OCCURRED ON THE IESU AT THE TIME OF THE EVENT. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2531914 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-68 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES