BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18000218 · Received October 24, 2023

    Report

    Report Number
    2955842-2023-19582
    Event Type
    Malfunction
    Date Received
    October 24, 2023
    Date of Event
    October 2, 2023
    Report Date
    October 2, 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
    WI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING UP AND IT INITIALLY DID POWER ON WITHOUT ERRORS. THE PROCEDURE WAS COMPLETED NOT USING MONOPOLAR ENERGY AND ONLY THE E-100 FOR THE BIPOLAR UNIT. ISI DID RECEIVE THE INTEGRATED ELECTROSURGICAL UNIT (IESU) GENERATOR TO PERFORM FAILURE ANALYSIS. IT WAS NOTED THAT THE IESU GENERATOR ENERGIZED AND CAUTERIZED, AND ALL PORTS RECOGNIZED INSTRUMENTS. THE M-02 WAS FOUND IN ERROR LOG.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE REPLACED THE ERBE TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE ERBE; HOWEVER, THE 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

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GYNECOLOGY SURGICAL PROCEDURE, THE SITE HAD AN INTERMITTENT N-08 ERROR ON THE GENERATOR. THE SITE WAS ABLE TO CLEAR THE ERROR BY RESEATING THE INSTRUMENT CORD. INTUITIVE TECHNICAL SERVICE ENGINEER (TSE) RECOMMENDED TO REBOOT THE ERBE IF POSSIBLE. THE SITE COULD NOT DO SO AT THE TIME AND CONTINUED WITH PROCEDURE. THE ERROR LOGS SHOW MULTIPLE 25913 (N-08 AND M-02) ERRORS POINTING TO THE ERBE GENERATOR. THE PROCEDURE WAS COMPLETED AS PLANNED 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
    1691360 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-39 N/A 00886874110898

    Patients

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