BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18461697 · Received January 8, 2024

    Report

    Report Number
    2955842-2023-21913
    Event Type
    Malfunction
    Date Received
    January 8, 2024
    Date of Event
    December 12, 2023
    Report Date
    December 12, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    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 ISI FSE WENT ON SITE AND REPLACED THE USM TO RESOLVE THE ERROR. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. THE ROOT CAUSE OF THE CUSTOMER-REPORTED FAILURE MODE COULD NOT BE DETERMINED AS THE PRODUCT WOULD NOT BEEN RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    PLEASE REFER TO THE FOLLOWING CORRECTED INFORMATION: ANNEX A CODE UPDATED TO A090209.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE UNIT CAME IN WITH A REPORTED 23094 ERROR ON AXIS 2 WHICH WAS CONFIRMED AND REPLICATED IN-HOUSE. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE WHERE THE 23094 ERROR WAS TRIGGERED. THE UNIT WAS ALSO TESTED ON A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE THE CHIP ENCODER VIRTUAL ABSOLUTE (CVA) CHARACTERIZATION FAILED FOR THE PITCH CVA. THE UNIT ALSO FAILED THE SENSORS CHECK FOR THE YAW. A GOLDEN PITCH CVA WAS INSTALLED, AND THE UNIT WAS ABLE TO PASS TESTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED TOTAL NEPHRECTOMY PROCEDURE, THE SITE WAS FACING AN ISSUE WITH THE UNIVERSAL SURGICAL MANIPULATOR 2 (USM). AN INTUITIVE (IS) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED FOR ASSISTANCE. THE ISI TSE REVIEWED THE SYSTEM EVENT LOGS AND NOTICED AN ERROR 23094 POINTING USM2 AXIS2. THE CALLER STATED THAT THEY TRIED A POWER CYCLE WITHOUT ANY SUCCESS AND THE ISI TSE ASKED THE CALLER TO PERFORM A HARD POWER CYCLE AND TO CLEAN THE BLUE FIBER CABLE (BFC) CONNECTOR (BECAUSE OF CODE 54 IN THE LOGS). AFTER RESTARTING, THE SYSTEM WAS READY. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY AND COMPLETED WITH NO REPORTED INJURY. ISI CONTACTED THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE ISSUE OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED LAPAROSCOPICALLY SURGERY WITH NO HARM AFTER CONVERSION TO LAPAROSCOPY FOR THE PATIENT. THE PROCEDURE WAS A TOTAL NEPHRECTOMY.

    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
    688056 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES