BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI XI

    MDR report key: 19627748 · Received June 27, 2024

    Report

    Report Number
    2955842-2024-16126
    Event Type
    Malfunction
    Date Received
    June 27, 2024
    Date of Event
    June 4, 2024
    Report Date
    June 4, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115343
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    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 NOTED THAT THE PROCEDURE WAS COMPLETED WITH AN EXTERNAL CAUTERY SOURCE. THE FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) DUE TO BIPOLAR ENERGY AND MONOPOLAR ENERGY WERE NOT FIRING. THE SYSTEM WAS TESTED AND VERIFIED AS READY TO USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE WAS ANALYZED AND WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. THE UNIT DISPLAYED C-34 ERRORS UPON CONSECUTIVE STARTUPS. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) TRANSFERRED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE TO THE ORIGINAL EQUIPMENT MANUFACTURER (OEM) FOR REPAIR. THE ERBE WAS CALIBRATED, AND A TECHNICAL SAFETY CHECK WAS PERFORMED VERIFYING THAT THE ERBE MEETS SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, ERROR C-34 OCCURRED ON THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) SUGGESTED TO REBOOT THE IESU. THE CUSTOMER CONFIRMED THE ISSUE WAS THE SAME AFTER THE REBOOT. THE CUSTOMER HAD TRIED ANOTHER ENERGY CABLE AND MOVED THE ENERGY CABLE TO ANOTHER MONOPOLAR PORT, BUT THE ISSUE PERSISTED. THE TSE ASSISTED THE CUSTOMER WITH CONNECTING AN EXTERNAL FORCE TRIAD GENERATOR FOR MONOPOLAR ENERGY. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE REPORTER INDICATED THAT THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM. THE SYSTEM INITIALLY POWERED ON WITHOUT ANY ERRORS.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2185158 DA VINCI XI VISION SIDE SYSTEM, RECONDITIONED NAY INTUITIVE SURGICAL, INC 380721-11 N/A 00886874115343

    Patients

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