BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19602846 · Received June 25, 2024

    Report

    Report Number
    2955842-2024-15908
    Event Type
    Malfunction
    Date Received
    June 25, 2024
    Date of Event
    May 29, 2024
    Report Date
    May 29, 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
    KS
    Reporter Occupation
    003

    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 CHECKED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) BIPOLAR ENERGY ACTIVATION, BUT THE FSE COULDN'T FIND ANY ISSUE. BUT THERE WAS IESU ERROR C-00 SEVERAL TIMES. SO, THE FSE REPLACED THE IESU AS A PROACTIVE ACTION AND THE SYSTEM WAS VERIFIED AND READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) AND COMPLETED THE DEVICE EVALUATION. THE UNIT WAS ANALYZED AND BUT THE REPORTED FAILURE (IESU ERROR MESSAGE DISPLAYED REPEATEDLY WHEN THE USER ACTIVATED BIPOLAR ENERGY) COULD NOT BE REPRODUCED. THE UNIT ENERGIZED AND CAUTERIZED AND ALL PORTS RECOGNIZED INSTRUMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, AN INTEGRATED ELECTROSURGICAL UNIT (IESU) ERROR MESSAGE DISPLAYED REPEATEDLY WHEN THE CUSTOMER ACTIVATED BIPOLAR ENERGY. THE CUSTOMER COULD NOT PROVIDE MORE DETAILS ON THE ERROR MESSAGE. PRIOR TO CALLING TECH SUPPORT, THE CUSTOMER ALREADY REPLACED THE IESU WITH AN EXTERNAL GENERATOR. ONSITE WAS NOT AVAILABLE AT THE MOMENT AND THE CUSTOMER COULD NOT CHECK THE EVENT LOGS. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON AND THE IESU INITIALIZED WITHOUT ERROR. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217859 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-46 N/A 00886874110898

    Patients

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