BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 19645102 · Received July 1, 2024

    Report

    Report Number
    2955842-2024-16490
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    June 4, 2024
    Report Date
    June 4, 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
    FI
    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 FSE REPLACED THE INTEGRATED ELECTROSURGICAL UNIT (IESU). THE SYSTEM WAS VERIFIED AND READY FOR USE. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE PRODUCT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INTEGRATED ELECTROSURGICAL UNIT (IESU) ASSOCIATED WITH THE CUSTOMER-REPORTED COMPLAINT. THE UNIT WAS ANALYZED AND WAS PLACED ON AN IN-HOUSE SYSTEM AND WAS RUN IN NORMAL MODE. THE UNIT ENERGIZED AND CAUTERIZED AND ALL PORTS RECOGNIZED INSTRUMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, AN ISSUE WITH THE ERBE INTEGRATED ELECTROSURGICAL UNIT (IESU) OCCURRED. THE ERBE GENERATOR ENCOUNTERED VARIOUS ERRORS DURING SURGERY, MAKING IT DIFFICULT TO USE THE BIPOLAR ENERGY. WHEN ERRORS OCCURRED, THE CUSTOMER REPLACED THE ENERGY CABLE AND THE INSTRUMENT ONCE, BUT FAULTS KEPT RETURNING. THE CUSTOMER REPORTED THAT SURGERY WAS COMPLETED, BUT WITH DIFFICULTIES. THERE WAS NO EFFECT TO PATIENT OUTCOME. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) VERIFIED SEVERAL ERBE ERRORS IN LOGS. TSE ADVISED AGAINST USING THE ERBE FOR NEXT SURGERY AND ASKED IF THEY HAD A BACKUP GENERATOR SUCH AS FORCE TRIAD. THE CUSTOMER INFORMED TSE THEY WOULD USE THE BACKUP ESU FOR NEXT SURGERY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE OPERATION WAS COMPLETED SUCCESSFULLY. THE SURGERY TIME WAS SLIGHTLY LONGER. BIPOLAR ENERGY WAS NOT USED DURING THE FINAL SURGERY. THE OPERATION WAS COMPLETED WITH THE HELP OF THE ROBOT. THE GENERATOR WAS NOT REPLACED IN THE MIDDLE OF THE OPERATION.

    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
    1256531 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-46 N/A 00886874110898

    Patients

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