BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21439692 · Received February 21, 2025

    Report

    Report Number
    2955842-2025-01435
    Event Type
    Malfunction
    Date Received
    February 21, 2025
    Date of Event
    January 28, 2025
    Report Date
    January 28, 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
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THIS UNIVERSAL SURGICAL MANIPULATOR (USM) WAS RETURNED FOR FAILURE ANALYSIS AND THE REPORTED ERROR 319, WAS CONFIRMED AND REPLICATED. IN LOGS, THE ERROR 319, WAS FOUND INDICATING THE AXIS CONTROLLER CARRIAGE (ACC), CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, THE ROLLING LOOP ASSEMBLY WAS FOUND DAMAGED THAT WOULD BE RELATED TO THE REPORTED EVENT. THE USM WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE 319 ERROR WAS TRIGGERED INDICATING A FAULT ON THE ACC, REPLICATING THE REPORTED EVENT. THE USM WAS THEN INSTALLED ONTO A PATIENT SIDE CART (PSC) FIXTURE TEST PLATFORM (PFTP) WHERE ¿CHECK ALL BOARDS¿ TEST WAS FOUND TO BE FAILING. ONCE TESTING WAS COMPLETED, THE ROLLING LOOP FIBER WAS VERIFIED TO BE THE SOURCE OF THE FAULT. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO A DEFECTIVE ROLLING LOOP FIBER ON THE USM ACC.

    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. FSE REPLACED UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS VERIFIED AND READY TO USE. ISI HAS RECEIVED THE USM FOR EVALUATION. HOWEVER, THE FAILURE ANALYSIS HAS NOT BEEN COMPLETED YET. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    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 SIGMOID COLECTOMY SURGICAL PROCEDURE, CUSTOMER CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) AND REPORTED A NON-RECOVERABLE ERROR. THE SYSTEM WAS LOCKED UP AND WAS UNRESPONSIVE TO POWER OFF REQUESTS. THE CUSTOMER PERFORMED A HARD POWER CYCLE AND RESTARTED THE SYSTEM. AN ERROR #319 WAS PRESENTED ON UNIVERSAL SURGICAL MANIPULATOR (USM) #1 AFTER HARD POWER CYCLE. THE SITE EXERCISED THE ARM AND ATTEMPTED TO HARD POWER CYCLE THE SYSTEM AND THE ERROR RETURNED AGAIN. THE CUSTOMER DISABLED THE USM, AND THE SYSTEM WAS READY FOR USE AS A THREE ARM. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE ISSUE WAS IDENTIFIED DURING PROCEDURE. PORTS WERE PLACED. THE SYSTEM DID INITIALLY POWER ON WITHOUT ERRORS. ACTIONS TAKEN TO RESOLVE THE REPORTED ISSUE/TO CONTINUE THE PROCEDURE WAS TO DISABLE THE ARM AND COMPLETED THE PROCEDURE WITH 3 ARMS. PROCEDURE WAS COMPLETED WITH NO INJURY TO THE PATIENT. THE SURGEON DID DISABLE THE ARM, AND THE PROCEDURE WAS COMPLETED WITH 3 ARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1267904 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-31 N/A 00886874110720

    Patients

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