BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20570185 · Received October 30, 2024

    Report

    Report Number
    2955842-2024-21316
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Date of Event
    October 4, 2024
    Report Date
    October 4, 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
    003

    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 GENERATOR 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 AND THE REPORTED FAILURE COULD NOT BE REPRODUCED. THE UNIT ENERGIZED AND CAUTERIZED, AND ALL PORTS RECOGNIZED INSTRUMENTS. THERE WERE NO ISSUES UPON MULTIPLE ACTIVATIONS. IN ERROR LOG M-0B, C-84, C-0. UPON VISUAL INSPECTION TOP COVER HAS A FEW SCRATCHES, ALSO HEAT SINK HAD MINOR SCRATCHES. THE COMPLAINT WAS NOT CONFIRMED BASED ON THE FAILURE ANALYSIS. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. FIELD E4 IS BLANK BECAUSE IT IS UNKNOWN IF THE INITIAL REPORTER SUBMITTED A REPORT TO THE FDA. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BILATERAL INGUINAL HERNIA SURGICAL PROCEDURE THAT THE BIPOLAR ENERGY WAS NOT WORKING. THE BIOMED REPORTING THE ISSUE CONFIRMED THAT THERE WAS AN AUDIBLE TONE AND BORDER HIGHLIGHTS, BUT NO ENERGY WAS BEING DELIVERED TO THE INSTRUMENT TIP OF THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT. THE INTUITIVE TECH SUPPORT ENGINEER (TSE) REVIEWED THE LIVE SYSTEM LOGS AND FOUND NO ENERGY RELATED MESSAGES. THE OPERATING ROOM (OR) STAFF CYCLED THE INTEGRATED ELECTRO SURGICAL GENERATOR UNIT (IESU) GENERATOR POWER. THERE STILL WAS NO CHANGE WITH THE BIPOLAR ENERGY. THE OR STAFF TRIED A SECOND BIPOLAR INSTRUMENT, WITH NO CHANGE. THE MONOPOLAR CAUTERY HOOK INSTRUMENT'S ENERGY WAS WORKING WITH NO ISSUES. THE TSE ASKED THE BIOMED TO CYCLE THE SYSTEM POWER. THE SURGEON WAS UNABLE TO CYCLE THE SYSTEM POWER DURING THE PROCEDURE. THE SURGEON CONTINUED WITH THE PROCEDURE ROBOTICALLY. THERE WERE NO REPORTS OF PATIENT INJURY. INTUITIVE FOLLOWED UP WITH THE CUSTOMER AND RECEIVED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM DID NOT PRESENT ANY ERRORS AT INITIAL POWER UP. THE IESU HAS BEEN REPLACED TWICE. THERE IS A POSSIBILITY THE REPORTED ISSUE IS RELATED TO THE SITE'S POWER SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1832835 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-43 N/A 00886874110898

    Patients

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