BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21300558 · Received February 3, 2025

    Report

    Report Number
    2955842-2025-01151
    Event Type
    Malfunction
    Date Received
    February 3, 2025
    Date of Event
    January 10, 2025
    Report Date
    January 10, 2025
    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
    PL
    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 FSE REPLACED THE OUTER DISTAL AND PROXIMAL SET UP JOINTS (SUJS) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE THE DA VINCI PRODUCTS INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE DISTAL SET-UP JOINT (SUJ) WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED ERROR 32115 WAS CONFIRMED AND REPLICATED. ERRORS 32115, 25730, AND 26002 WERE FOUND, INDICATING A COMMUNICATION ERROR OCCURRED, AND CONFIRMING THAT THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE SETUP FIELD REPLACEABLE UNIT (FRU) LOWER (SFL) PRINTED CIRCUIT ASSEMBLY (PCA) WAS DAMAGED, AND RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE ERRORS 25730, 32115, AND 26002 WERE TRIGGERED INDICATING A COMMUNICATION ERROR, REPLICATING THE REPORTED EVENT. THE UNIT WAS THEN INSTALLED ONTO A TESTING PLATFORM WHERE THE UNIT FAILED THE NODE CHECK. INSTALLED A GOLDEN SFL PCA AND RETESTED THE UNIT WITH PASSING RESULTS. AS A RESULT OF THE TESTING, FAILURE ANALYSIS WAS ABLE TO CONCLUDE THAT THE SFL PCA WAS THE ROOT CAUSE OF THE REPORTED EVENT. IN ADDITION, THE PROXIMAL SET-UP JOINT (SUJ) WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED 32115 ERROR WAS CONFIRMED AND REPLICATED. ERROR 32115 WAS FOUND IN THE LOGS, INDICATING A LOSS OF COMMUNICATION, CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE 32115 ERROR WAS TRIGGERED, REPLICATING THE REPORTED EVENT. THE UNIT WAS THEN INSTALLED ONTO A TESTING PLATFORM AND THE AXES CONTROLLER SETUP (ACU) PCA WAS FOUND TO BE THE ROOT CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, SITE CONTACTED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) TO REPORT THAT SYSTEM ENCOUNTERED REPEATED RECOVERABLE FAULTS RELATED TO UNIVERSAL SURGICAL MANIPULATOR (USM) 1. TSE CHECKED LOGS AND NOTED WHEEL ERRORS POINTING AT COMMUNICATION BETWEEN AXES CONTROLLER SETUP (ACU) AND AXES CONTROLLER TORNADO (ACT) BOARDS IN USM 1. THE TSE ASKED IF SITE COULD PROCEED WITH THREE USMS, AND SITE STATED THEY COULD NOT. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM AND NO MALFUNCTION WAS NOTICED AFTER THE SYSTEM WAS STARTED, SELF- TEST COMPLETED AS USUAL. THE SYSTEM INITIALLY POWERED ON WITHOUT ERRORS. USM ERROR OCCURRED UNEXPECTEDLY IN THE MIDDLE OF THE SURGERY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54220 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-54 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES