BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18585089 · Received January 25, 2024

    Report

    Report Number
    2955842-2024-10682
    Event Type
    Malfunction
    Date Received
    January 25, 2024
    Date of Event
    January 4, 2024
    Report Date
    January 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
    CH
    Reporter Occupation
    BIOMEDICAL ENGINEER
    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 WAS ABLE TO REPRODUCE THE REPORTED COMPLAINT AND REPLACED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE IESU INVOLVED WITH THIS COMPLAINT. FAILURE ANALYSIS CONFIRMED THE REPORTED M-32 DURING THE SYSTEM START UP. THE ERROR LOGS SHOWED ERRORS M-02-5, M-02, C-00, AND M-36.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, THE SYSTEM HAD AN ERROR C-82 OCCUR ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE CUSTOMER USED ANOTHER ENERGY PLATFORM. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. AN INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM. THE IESU INITIALLY POWERED ON WITHOUT ERRORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016525 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-65 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES