BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18320707 · Received December 13, 2023

    Report

    Report Number
    2955842-2023-21239
    Event Type
    Malfunction
    Date Received
    December 13, 2023
    Date of Event
    November 16, 2023
    Report Date
    November 16, 2023
    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 ELECTROSURGICAL UNIT (IESU) TO RESOLVE THE M-31 ERRORS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE IESU INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE IESU ENERGIZED AND CAUTERIZED ALL PORTS AND RECOGNIZED INSTRUMENTS. THE COMPLAINT WAS NOT CONFIRMED BASED ON THE FAILURE ANALYSIS EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GENERAL SURGICAL PROCEDURE, THE CUSTOMER WAS GETTING C-00 AND M-31 FAULTS ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU) WHILE USING HANDHELD INSTRUMENTS. THE CUSTOMER STATED THAT THEY REPLACED THE INSTRUMENT AND POWER CYCLED THE IESU, BUT FAULTS PERSISTED. THE CUSTOMER WAS CONTINUING WITHOUT TROUBLESHOOTING FURTHER. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION. THE CUSTOMER HAD TO BRING IN AN ADDITIONAL GENERATOR FROM ANOTHER ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1824601 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-38 N/A 00886874110898

    Patients

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