BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19956062 · Received August 9, 2024

    Report

    Report Number
    2955842-2024-17536
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    July 16, 2024
    Report Date
    July 16, 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
    CA, 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 INTEGRATED ELECTRO SURGICAL UNIT (IESU) 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. THE IESU WAS ANALYZED BUT THE REPORTED FAILURE COULD NOT BE REPRODUCED. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM. THE UNIT ENERGIZED AND CAUTERIZED ALL PORTS AND RECOGNIZED INSTRUMENTS. THE UNIT HAD SMALL SCRATCHES THROUGHOUT COVER. HEAT SINKS SHOWING SIGNS OF DISCOLORATION(SILVERING). NO OTHER MAJOR DENTS OR SCRATCHES IDENTIFIED. THE COMPLAINT WAS NOT CONFIRMED BASED ON THE FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE BIPOLAR ENERGY WAS NOT WORKING WHEN THE CUSTOMER ATTEMPTED TO USE A FENESTRATED BIPOLAR FORCEPS INSTRUMENT ON THE UNIVERSAL SURGICAL MANIPULATOR 3 (USM3). THE CUSTOMER HAD CHANGED THE INSTRUMENT ENERGY CABLE TWICE AND TRIED USING ANOTHER INSTRUMENT, BUT THE ISSUE PERSISTED. THE CUSTOMER CONFIRMED THAT THE INSTRUMENT WAS RECOGNIZED ON THE INTEGRATED ELECTRO SURGICAL UNIT ERBE AND THE USM3. THE CUSTOMER RECEIVED PHONE ASSISTANCE FROM AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE). THE TSE REVIEWED THE SYSTEM LOGS AND THERE WERE NO RELATED ERRORS. THE TSE RECOMMENDED THE CUSTOMER USING THE OTHER BIPOLAR ENERGY PORT. THE CUSTOMER HAD INSTALLED A PERMANENT CAUTERY HOOK ON THE USM 3 AND IT WAS WORKING NORMALLY. THE CUSTOMER ELECTED TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WERE NO ISSUES WITH THE SYSTEM DURING POWERUP. THE ISSUE OCCURRED DURING THE SECOND PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME GENERATOR WITHOUT USING BIPOLAR ENERGY. THE PROCEDURE WAS COMPLETED WITH THE PERMANENT CAUTERY HOOK INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2485635 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-41 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES