BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20691942 · Received November 14, 2024

    Report

    Report Number
    2955842-2024-21864
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    October 21, 2024
    Report Date
    October 21, 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
    CO, US
    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 REPLACED THE INTEGRATED ELECTRO SURGICAL GENERATOR UNIT (IESU) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE IESU WAS ANALYZED AND THE REPORTED FAILURE WAS CONFIRMED AND REPRODUCED. THE UNIT FUSES WERE REPLACED WITH THE NEW V8 FUSES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE TO BYPASS REVISION SURGICAL PROCEDURE, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL TERRITORY ASSOCIATE (CTA) INFORMED THE ISI TECHNICAL SUPPORT ENGINEER (TSE) THAT THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) LOST THE POWER. THE CTA CONFIRMED THAT THE IESU POWER CABLE WAS CONNECTED TO THE WALL POWER OUTLET PROPERLY. THE CUSTOMER WAS NOT ABLE TO SWAP TO ANOTHER WALL POWER OUTLET BECAUSE IT WAS NOT CLOSE ENOUGH. THE CUSTOMER ALSO CONFIRMED THAT THE WALL POWER OUTLET WAS NORMAL AFTER TESTING WITH ANOTHER PIECE OF EQUIPMENT. THE CUSTOMER USED THE E-100 GENERATOR TO CONTINUE WITH THE CASE. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PROCEDURE WAS ABLE TO BE COMPLETED ROBOTICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169314 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

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