BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18107184 · Received November 9, 2023

    Report

    Report Number
    2955842-2023-20101
    Event Type
    Malfunction
    Date Received
    November 9, 2023
    Date of Event
    October 24, 2023
    Report Date
    October 24, 2023
    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
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL INC. (ISI) FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND REPLACED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) TO RESOLVE THE MONOPOLAR ENERGY ISSUE. ISI HAS RECEIVED THE IESU; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN FAILURE ANALYSIS HAS COMPLETED THEIR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) WAS ANALYZED. THE REPORTED FAILURE WAS NOT REPRODUCED. THE UNIT ENERGIZED AND CAUTERIZED AT ALL PORTS AND RECOGNIZED INSTRUMENTS. THE ERROR LOGS SHOWED ERROR M-0B OCCURRED.

    Additional Manufacturer Narrative · 0

    REFER TO IMDRF CODE D FOR CORRECTED INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, THE MONOPOLAR ENERGY WAS NOT WORKING. THE CUSTOMER TRIED TWO SETS OF INSTRUMENTS, AND INSTRUMENT CABLES, BUT THE ISSUE PERSISTED. THE INTUITIVE SURGICAL INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASKED THE CUSTOMER TO POWER CYCLE THE INTEGRATED ELECTRO SURGICAL UNIT (IESU), BUT THE ISSUE REMAINED. THE TSE THEN ADVISED THE CUSTOMER TO TRY A THIRD INSTRUMENT CABLE, BUT THE SURGEON DECLINED. THE TSE ALSO SUGGESTED PERFORMING A POWER CYCLE OF THE SYSTEM AND IESU. THE SURGEON OPTED TO MOVE FORWARD WITHOUT TAKING THOSE ACTIONS. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    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
    1832205 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-12 N/A

    Patients

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