BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18080959 · Received November 6, 2023

    Report

    Report Number
    2955842-2023-19945
    Event Type
    Malfunction
    Date Received
    November 6, 2023
    Date of Event
    October 20, 2023
    Report Date
    October 20, 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
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ERBE UNIT WAS EVALUATED BY THE ORIGINAL EQUIPMENT MANUFACTURER (OEM). THE REPORTED FAILURE WAS CONFIRMED WHEN THE ERBE UNIT PRODUCED A U-02 ERROR ON STARTUP, INDICATING A MALFUNCTION SYSTEM CHECK MASTER PRINTED CIRCUIT BOARD (PCB). THE FRONT FRAME BEZEL WAS ALSO FOUND TO BE CRACKED.

    Additional Manufacturer Narrative · 0

    THE FAILURE ANALYSIS INVESTIGATION WAS COMPLETED FOR THE ERBE INTEGRATED ELECTROSURGICAL UNIT (IESU) GENERATOR. THE REPORTED FAILURE (U-02 ERROR ON START-UP) WAS CONFIRMED AND REPRODUCED. THE IESU WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE.

    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 ERBE DUE TO THE REPEATED U-02 ERRORS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE ERBE; HOWEVER, FAILURE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) CALLED TECHNICAL SUPPORT ENGINEER (TSE) AND STATED THAT THE SITE WAS HAVING ISSUES WITH THE ERBE. THE SITE WAS GETTING U-02 ERRORS ON THE ERBE. THE SITE HAD BROUGHT IN A FORCE TRIAD TO COMPLETE THE CASE. THE SITE WAS COMPLETING THE PROCEDURE AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339115 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-36 N/A 00886874110898

    Patients

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