BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21358625 · Received February 11, 2025

    Report

    Report Number
    2955842-2025-01477
    Event Type
    Malfunction
    Date Received
    February 11, 2025
    Date of Event
    January 17, 2025
    Report Date
    January 17, 2025
    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
    TX, 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. THE FSE REPLACED THE INTEGRATED ELECTRO SURGICAL GENERATOR UNIT (IESU) TO RESOLVE THE ISSUE. THE FSE ALSO RESOLVED AN UNRELATED NETWORK CONNECTION 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 ON THE IESU/ERBE CONNECTED TO SYSTEM. LOGS SHOWED (25913 2-8A ERRORS 1/17/2025) VISUAL INSPECTION: (THE UNIT HAS NO SIGNIFICANT SCRATCHES OR DENTS. THE FRONT BEZEL IS IN DECENT CONDITION.) THE UNIT ENERGIZED AND CAUTERIZED AND ALL PORTS RECOGNIZED INSTRUMENTS ON SYSTEM M-B0-60 ERROR OCCURRED TWO TIMES. (2-8A ERROR) POTENTIAL ROOT CAUSE FOR THIS ISSUE. THE COMPLAINT WAS CONFIRMED BASED ON THE FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO ELECTRICAL DEFECT OF THE IESU.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LYMPHADENECTOMY SURGICAL PROCEDURE THAT MONOPOLAR OUTPUT WAS INTERMITTENT AT BOTH THE TOP AND BOTTOM MONOPOLAR OUTPUT CONNECTORS. THE CALLER USED X3 DIFFERENT MONOPOLAR CURVED SCISSOR (MCS) INSTRUMENTS, AND X3 DIFFERENT GREEN MONOPOLAR ENERGY CABLES, WITH NO CHANGE. THE CALLER ADVISED THAT THIS ISSUE OCCURRED ON THE PREVIOUS CASE, AND CABLE REPLACEMENT RESOLVED THE ISSUE. THE NETWORK WAS NOT CONNECTED. THE INTUITIVE TECHNICAL SUPPORT ENGINEER (TSE) ASKED THE CALLER IF THEY TRACKED THE USES OF THEIR ENERGY CABLES; THEY DID NOT. THE TSE ADVISED THAT MULTIPLE FAILED ENERGY CABLES COULD HAVE BEEN THE CAUSE OF THE ISSUE, AND RECOMMENDED ADDITIONAL REPLACEMENTS. THE SURGEON PROCEEDED BY USING A SYNCHROSEAL INSTRUMENT. THERE WERE NO REPORTS OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE DID OCCUR FROM SYSTEM SK4490. THE NEW INTEGRATED ELECTRO SURGICAL GENERATOR UNIT (IESU) DID NOT SHOW ANY ERRORS FROM PREVIOUS IESUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793932 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DA VINCI INSTRUMENTS AND ACCESSORIES