BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17733386 · Received September 12, 2023

    Report

    Report Number
    2955842-2023-18413
    Event Type
    Malfunction
    Date Received
    September 12, 2023
    Date of Event
    August 18, 2023
    Report Date
    August 18, 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
    SP
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE VIO INTEGRATED ELECTRO SURGICAL UNIT (IESU) GENERATOR INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS (FA) EVALUATION. FA WAS ABLE TO CONFIRM/REPRODUCE THE REPORTED COMPLAINT WHEN THE UNIT WAS PLACED ON AN IN-HOUSE SYSTEM AND RUN IN NORMAL MODE.

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ERROR C-38, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) REPLACED THE INTEGRATED ELECTRO SURGICAL UNIT (IESU) ERBE TO RESOLVE THE ISSUE. ISI RECEIVED THE ERBE INVOLVED WITH THIS COMPLAINT; HOWEVER, FAILURE ANALYSIS IS IN PROGRESS. A FOLLOW-UP 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 RADICAL WITHOUT LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, A CUSTOMER CALLED TO REPORT THEY WERE HAVING ERROR "C-38" WHENEVER THEY TRIED TO APPLY MONOPOLAR ENERGY. BEFORE CALLING INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE), THEY HAD ALREADY REBOOTED THE ERBE A FEW TIMES AND REPLACED THE CAUTERY CABLE AND MONOPOLAR INSTRUMENT WITHOUT SUCCESS. THE ISI TSE REVIEWED ERROR LOGS AND FOUND SEVERAL INSTANCES OF ERROR C-38. THE ISI TSE RECOMMENDED THE CALLER TO LOOK FOR A FORCETRIAD TO HAVE AN ALTERNATIVE. THE CALLER FOUND A FORCETRIAD BUT NOT THE ACTIVATION CABLE. THE ISI TSE CONTACTED THE CLINICAL SALES REPRESENTATIVE (CSR) WHO INFORMED THE CUSTOMER ABOUT THE ACTIVATION CABLE LOCATION. THE ISI TSE GUIDED THE CALLER THROUGH ACTIVATION CABLE CONNECTIVITY. THEY TESTED THE CONFIGURATION, AND THEY WERE ABLE TO CONTINUE USING FORCETRIAD. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446917 DAVINCI XI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 381121-41 N/A 00886874110898

    Patients

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