BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21954901 · Received May 2, 2025

    Report

    Report Number
    2955842-2025-18296
    Event Type
    Malfunction
    Date Received
    May 2, 2025
    Date of Event
    April 15, 2025
    Report Date
    April 15, 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
    CO, 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 WENT ON-SITE AND REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE SYSTEM WAS READY FOR USE. INTUITIVE SURGICAL INC. (ISI) RECEIVED THE IESU FOR FAILURE ANALYSIS INVESTIGATION. THE UNIT WAS ANALYZED AND THE REPORTED FAILURE (ERBE HAS A RED QUESTION MARK BY THE ENERGY PLUGS, HARD FAULT AT STAR UP.) WAS CONFIRMED AND REPRODUCED ON ERBE CONNECTED TO SYSTEM. REMOTEFE SHOWED (25913 M-02 ERRORS 4/14/2025.) VISUAL INSPECTION:( THE UNIT HAS NO SIGNIFICANT SCRATCHES OR DENTS. THE FRONT BEZEL IS IN DECENT CONDITION.) (M-02-3 ERROR ON START-UP, AND RED QUESTION MARKS BY MONO/BIPOLAR PORTS. (INSTRUMENTS NOT DETECTED.)) ERBE UNIT THAT WAS PLACED ON GOLDEN SYSTEM AND WAS RUN IN NORMAL MODE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, USER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT A RED QUESTION MARK APPEARED ON THE ERBE'S SCREEN. THE TSE REVIEWED THE SYSTEM ERROR LOGS BUT FOUND NO RELATED ERRORS. PRIOR TO CALLING, THE USER HAD POWER CYCLED THE ERBE AND RESEATED THE ENERGY CORD, BUT THE ISSUE PERSISTED. THE TSE INFORMED TO THE USER THAT A QUESTION MARK WOULD DISPLAY ON THE ERBE IN THE ABSENCE OF A CONNECTED ENERGY CABLE AND ADVISED REPLACING THE ENERGY CABLE IF THE ISSUE CONTINUED. THE USER CONTINUED WITH THE PROCEDURE WITHOUT USING THE ERBE GENERATOR. A PROCEDURE DELAY WAS REPORTED. ISI MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187852 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-17 N/A 00886874110898

    Patients

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