BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18540773 · Received January 19, 2024

    Report

    Report Number
    2955842-2024-10398
    Event Type
    Malfunction
    Date Received
    January 19, 2024
    Date of Event
    December 26, 2023
    Report Date
    December 26, 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
    PA, 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 ISI FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) DUE TO ERROR MESSAGE OBSERVED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. ISI HAS RECEIVED THE PART; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN FAILURE ANALYSIS HAS COMPLETED THEIR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE IESU ERBE GENERATOR INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. REVIEW OF THE SYSTEM LOGS CONFIRMED THE FAILURE. THE GENERATOR WAS ANALYZED AND FOUND TO HAVE NO ISSUE. THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. A DEFECTIVE COMPONENT WAS SUSPECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY-BENIGN SURGICAL PROCEDURE, ERROR U-02 WAS OBSERVED. THE ERROR WAS INTERMITTENTLY POPPING UP WHILE IN USE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) WAS GOING TO WALK THE CUSTOMER THROUGH PULLING THE POWER CORD FROM THE ERBE WHILE THE ERROR WAS PRESENT. THE NEXT STEP WAS TO PLUG THE POWER CORD BACK IN AND POWER UP THE ERBE. WHILE ON THE PHONE, THE ERROR WAS NOT SHOWING, AND THE CUSTOMER WAS GOING TO TRY THE STEPS MENTIONED IN THE ERROR RETURNED. THE CUSTOMER REPORTED THE U-02 ERROR RETURNED AND WILL NO LONGER CLEAR. PRIOR TO CALLING CUSTOMER RESTARTED THE ERBE WITH NO CHANGE. THE CUSTOMER WAS CONTINUING WITH THE PROCEDURE ROBOTICALLY AS PLANNED TO INCORPORATE LAPAROSCOPIC INSTRUMENTS TO AID WITH CAUTERY. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140006 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-40 N/A 00886874110898

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female DA VINCI INSTRUMENTS AND ACCESSORIES.