BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 20242396 · Received September 17, 2024

    Report

    Report Number
    2955842-2024-19552
    Event Type
    Malfunction
    Date Received
    September 17, 2024
    Date of Event
    August 21, 2024
    Report Date
    August 23, 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
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION HAS BEEN COMPLETED FOR THE SET UP JOINT (SUJ) AND THE THE REPORTED 319 ERROR WAS CONFIRMED AND REPLICATED. ERROR 319 WAS CONFIRMED INDICATING NODE CHECK FAILURES. THE DISTAL SUJ WAS INSTALLED ONTO GOLDEN SYSTEM WHERE ERROR 319 WAS REPLICATED. THE UNIT WAS TESTED ON A TEST PLATFORM WHERE IT FAILED NODE CHECKS. THE AXES CONTROLLER TORNADO (ACT) AND SETUP FRU LOWER (SFL) BOARDS WERE INSTALLED ONTO A TEST SYSTEM AND THE UNIT CONTINUED TO FAIL NODE CHECKS. VISUAL INSPECTION FOUND THE P2 CABLE TO BE PINCHED DUE TO EXCESSIVE TWISTING. AS A RESULT OF THESE FINDINGS, FAILURE ANALYSIS CONCLUDED THAT THE LOW VOLTAGE DIFFERENTIAL SIGNALING (LVDS) CABLE ASSEMBLY IS CONSISTENT WITH THE REPORTED PROBLEM AND COULD BE 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 REPORTED COMPLAINT AND REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) AND DISTAL INNER SET UP JOINT (SUJ) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE USM OR THE SUJ FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) AND DISTAL INNER SET UP JOINTS (SUJ) INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. EVALUATION HAS BEEN COMPLETED FOR THE USM AND THE ERROR WAS CONFIRMED BUT NOT REPLICATED. ERROR 319 WAS FOUND IN THE LOGS INDICATING A PRINTED CIRCUIT ASSEMBLY (PCA) BOARD FAULT ON THE AXES CONTROLLER ARM (ACA), CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE USM WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE COMPONENT FUNCTIONED AS EXPECTED. THE USM WAS THEN INSTALLED ONTO A TEST PLATFORM WHERE ALL RELEVANT TESTING PASSED WITHIN SPECIFICATION. ONCE TESTING WAS COMPLETED, THE ACA BOARD WAS INSPECTED, AND NO FAULTS COULD BE IDENTIFIED. FAILURE ANALYSIS IS IN PROGRESS FOR THE SUJS AS OF THE DATE OF THIS REPORT.

    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 SURGICAL PROCEDURE, THE SYSTEM SHOWED ERROR 319 ON ARM 3. THE SURGICAL TEAM TRIED TO RESTART THE SYSTEM, BUT WITHOUT SUCCESS. IT WAS NECESSARY TO DISABLE THE ARM 3 TO FINISH THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE DISTRIBUTOR'S CLINICAL SALES REPRESENTATIVE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ROBOTIC SYSTEM FAILED ON THE SECOND PROCEDURE OF THE DAY, HAVING PERFORMED THE FIRST SURGERY WITHOUT A FAILURE. THE SYSTEM WAS SWITCHED ON BEFORE THE PATIENT ARRIVED IN THE OPERATING ROOM AND DID NOT SHOW ANY ERRORS. THE FIELD SERVICE ENGINEER (FSE) WENT TO THE SITE AND THE SYSTEM WAS RELEASED FOR USE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1226942 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-51 N/A 00886874110720

    Patients

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