BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20881823 · Received December 9, 2024

    Report

    Report Number
    2955842-2024-22939
    Event Type
    Malfunction
    Date Received
    December 9, 2024
    Date of Event
    November 12, 2024
    Report Date
    November 12, 2024
    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
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TH PROXIMAL SET-UP JOINT (SUJ) WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED 40067 ERROR WAS CONFIRMED BUT NOT REPLICATED. IN LOGS, THE 40067 ERROR WAS FOUND INDICATING A COMMUNICATION ERROR, CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE SUJ WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THE SUJ WAS THEN INSTALLED WHERE ALL RELEVANT TESTING WAS PASSED WITHIN SPECIFICATION. ONCE TESTING WAS COMPLETED, THE SYSTEM WAS INSPECTED, AND NO FAULTS COULD BE IDENTIFIED. AS A RESULT OF THESE FINDINGS, FAILURE ANALYSIS CONCLUDED THAT THE AXES CONTROLLER SETUP (ACU) PRINTED CIRCUIT ASSEMBLY (PCA) WAS CONSISTENT WITH THE REPORTED EVENT AND WAS THE POTENTIAL ROOT CAUSE FOR THIS ISSUE. THE DISTAL SUJ WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED 40067 ERROR WAS CONFIRMED BUT NOT REPLICATED. IN LOGS, THE 40067 ERROR WAS FOUND INDICATING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, THE PINS WERE BROKEN OFF AND THE OTHER SET OF PINS WAS SMASHED TOGETHER AND FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE SUJ WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE UNIT FAILED THE NODE CHECK. THE SUJ WAS THEN INSTALLED WITH A GOLDEN SETUP FRU LOWER (SFL) PCA AND THE UNIT PASSED ALL TESTS. AS A RESULT THESE FINDINGS, FAILURE ANALYSIS CONCLUDED THAT THE SFL PCA WAS CONSISTENT WITH THE REPORTED EVENT AND WAS THE POTENTIAL ROOT CAUSE FOR THIS ISSUE.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS ABLE TO REPRODUCE THE ISSUE AND REPLACED THE PROXIMAL SETUP JOINT (SUJ) AND DISTAL (SUJ). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS NOT RECEIVED THE PROXIMAL SUJ OR DISTAL SUJ FOR EVALUATION. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. FIELD D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. FIELDS G5 AND G7 ARE NOT APPLICABLE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, RECOVERABLE FAULT 40067 OCCURRED. THE ERROR PERSISTED EVEN AFTER A REBOOT OF THE SYSTEM. THE PROCEDURE WAS REPORTEDLY BEING COMPLETED AS PLANNED, WITH NO REPORTS OF PATIENT INJURY. AT THIS TIME, IT IS UNKNOWN IF THE CUSTOMER HAD TO DISABLE AN ARM TO CONTINUE THE PROCEDURE. AN INTUITIVE SURGICAL, INC. (ISI) CONTACTED THE ISI TECHNICAL SUPPORT ENGINEER (TSE) AND RECEIVED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM INITIALLY POWERED ON WITH NO ERRORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1505287 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES