BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20108980 · Received August 30, 2024

    Report

    Report Number
    2955842-2024-18876
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    August 7, 2024
    Report Date
    August 7, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. FSE REPLACED INTEGRATED ELECTROSURGICAL UNIT (IESU) TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. INTUITIVE SURGICAL, INC. (ISI) HAS ISSUED A RETURN MATERIAL AUTHORIZATION (RMA) TO HAVE THE IESU RETURNED FOR EVALUATION. HOWEVER, ISI HAS NOT RECEIVED THE PRODUCT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE GENERATOR ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. THE UNIT WAS RETURNED FOR FAILURE ANALYSIS, BUT THE REPORTED FAILURE (ERROR M-02) COULD NOT BE REPRODUCED. 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 PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER HAD CONSTANT M-02 ERRORS ON THE INTEGRATED ELECTRO SURGICAL UNIT (IESU/ERBE) WHEN ACTIVATING THE MONOPOLAR ENERGY. PRIOR TO CONTACTING INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE), THE CUSTOMER ALREADY CHANGED THE CAUTERY CABLES AND TRIED DIFFERENT PORTS AND INSTRUMENTS. THE TSE CHECKED THE SYSTEM LOGS AND CONFIRMED THE ERROR. ALSO, MULTIPLE RESTARTS OF THE GENERATOR DID NOT SOLVE THE ISSUE. THE IESU CONNECTED TO A DEDICATED POWER OUTLET. THE CUSTOMER CONTINUED THE PROCEDURE USING THE BIPOLAR INSTRUMENTS ONLY. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY.

    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
    1802332 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-36 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male DA VINCI INSTRUMENTS AND ACCESSORIES