BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17375802 · Received July 24, 2023

    Report

    Report Number
    2955842-2023-17227
    Event Type
    Malfunction
    Date Received
    July 24, 2023
    Date of Event
    June 26, 2023
    Report Date
    June 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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING U-02 ERROR, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER ARRIVED AND THE VIO INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) POWERED ON WITH U-02 ERROR. THE FSE REPLACED THE IESU TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND WAS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE ERBE WAS ANALYZED AND FOUND THE FAILURE WAS NOT REPLICATED. THE COMPLAINT REGARDING U-02 ERBE ERROR WAS NOT CONFIRMED BASED ON FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT WHILE TRYING TO USE THE VIO INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) THEY HAD ERROR U-02 OCCUR. THE TSE RECOMMENDED TRYING TO RESET THE IESU BY DISCONNECTING THE FOOT PEDAL CABLES AND RCB CABLE, THEN UNPLUGGED THE IESU WHILE STILL ON AND RECONNECTING CABLES. THE IESU POWERED ON WITH NO ERROR BUT SHORTLY AFTER PRODUCED ANOTHER U-02 ERROR. THE CUSTOMER STATED THEY DID NOT HAVE A BACKUP GENERATOR, THE TSE RECOMMENDED USING ANOTHER DA VINCI SYSTEM VISION SIDE CART (VSC) TO FINISH THE CASE. THE CUSTOMER STATED THEY WERE GOING TO GET THE SECOND VSC AND COMPLETE THE CASE WITH IT AND WOULD CALL BACK IF THEY HAD CONNECTING ISSUES. THE PROCEDURE WAS CONVERTED TO ANOTHER DV SYSTEM WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795070 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-33 N/A 00886874110898

    Patients

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