BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19377109 · Received May 22, 2024

    Report

    Report Number
    2955842-2024-14519
    Event Type
    Malfunction
    Date Received
    May 22, 2024
    Date of Event
    April 29, 2024
    Report Date
    April 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
    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 INSTALLED INTEGRATED ELECTROSURGICAL UNIT (IESU) ACCORDING TO THE ISI PROCEDURES. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) AND COMPLETED THE DEVICE EVALUATION. THE IESU WAS ANALYZED AND THE REPORTED FAILURE (U-02 ERRORS ON START) WAS CONFIRMED AND REPRODUCED. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GENERAL CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED TO TECHNICAL SERVICE ENGINEER (TSE) THAT SYSTEM WAS THROWING AN ACTIVATION ERROR. TSE VIEWED LOGS AND NOTED U-02 ERROR. TSE HAD THE CUSTOMER PERFORM HARD REBOOT ON INTEGRATED ELECTROSURGICAL UNIT (IESU) WITH NO CHANGE. TSE RECOMMENDED BRINGING IN ANOTHER DV TOWER, BUT THE CUSTOMER STATED THAT THEY ONLY HAD ONE ROBOT. TSE HAD THE CUSTOMER CONNECT FORCE TRIAD GENERATOR USING THE ENERGY ACTIVATION CABLE. THE CUSTOMER WAS ABLE TO SUCCESSFULLY CONNECT A FORCE TRIAD GENERATOR AND ARE CONTINUING WITH PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1994374 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-30 N/A 00886874110898

    Patients

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