BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20867021 · Received December 6, 2024

    Report

    Report Number
    2955842-2024-22862
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    November 15, 2024
    Report Date
    November 15, 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
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE ERBE WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED FAILURE (U-02 FAULTS) WAS CONFIRMED AND REPRODUCED. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE AND ERROR U-02 KEPT OCCURRING ON START-UP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, ROBOTIC COORDINATOR (ROCO) CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) AND REPORTED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE ENCOUNTERED REPEATED U-02 FAULTS. TSE HAD CUSTOMER HARD CYCLE THE ERBE AND RESEAT CABLES, BUT FAULTS PERSISTED. TSE THEN HAD CUSTOMER HARD CYCLE VISION SIDE CART (VSC) AND ERBE, BUT ISSUES STILL PERSISTED. TSE ASKED IF THEY HAD A SECONDARY VISION SIDE CART (VSC) OR THIRD-PARTY ESU. CUSTOMER STATED THAT THEY DID NOT HAVE ANY SECONDARY TOWERS AVAILABLE AS THEY WERE RUNNING ALL SEVEN SYSTEMS TODAY. CUSTOMER STATED THAT THEY DID HAVE A THIRD-PARTY ESU BUT DID NOT HAVE THE ENERGY ACTIVATION CABLE. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE E-100 HAD U-02 FAULTS. UNKNOWN IF PORTS WERE PLACED. THE PROCEDURE WAS COMPLETED ROBOTICALLY. REPORTER WAS UNABLE TO CONFIRMED IF A THIRD-PARTY GENERATOR WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2119843 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-43 N/A 00886874110898

    Patients

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