BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 21810046 · Received April 9, 2025

    Report

    Report Number
    2955842-2025-14025
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Date of Event
    March 23, 2025
    Report Date
    March 23, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM4) DUE TO 319 ERROR. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE COMPLAINT WAS CONFIRMED BASED ON FIELD EVALUATION. ISI HAS RECEIVED THE USM FOR EVALUATION, BUT EVALUATION HAS NOT BEEN COMPLETED AS OF THE DATE OF THIS REPORT.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS RETURNED FOR FAILURE ANALYSIS, AND THE REPORTED 319 ERROR WAS CONFIRMED AND REPLICATED. IN SYSTEM LOGS, THE 319 ERROR WAS FOUND INDICATING NODE NOT PRESENT ON THE USM AXES CONTROLLER CARRIAGE (ACC) PRINTED CIRCUIT ASSEMBLY (PCA), CONFIRMING THE FAULT OCCURRED IN THE FIELD. UPON VISUAL INSPECTION, THE ROLLING LOOP FIBER WAS FOUND MISALIGNED THAT WOULD BE RELATED TO THE REPORTED EVENT. THE USM WAS INSTALLED ONTO A GOLDEN SYSTEM WHERE THE 319 ERROR WAS TRIGGERED, INDICATING FAULT ON THE ACC PCA, REPLICATING THE REPORTED EVENT. THE USM WAS THEN INSTALLED ONTO A PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) WHERE 319 WAS FOUND TO BE FAILING ON THE ACC PCA. ONCE TESTING WAS COMPLETED, THE ROLLING LOOP FIBER WAS ABA TESTED AND WAS VERIFIED TO BE THE SOURCE OF THE FAULT. THE PROBABLE ROOT CAUSE IS ATTRIBUTED TO THE ROLLING LOOP FIBER COMPONENT FAILURE CAUSED BY A STRESS PROBLEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE UNIVERSAL SURGICAL MANIPULATOR (USM4) HAD A 319 ERROR. THE SYSTEM WAS RESTARTED AND HARD POWER CYCLED, BUT THE ISSUE REMAINED. THE SURGEON REQUIRED ALL FOUR USMS FOR THIS PROCEDURE. A PATIENT SIDE CART (PSC) THAT WAS NOT IN USE AND WAS BROUGHT INTO THE ROOM. THE SYSTEM WAS RESTARTED WITH THE NEW PSC AND THE PROCEDURE WAS RESUMED ROBOTICALLY. THERE WERE NO REPORTS OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WERE NO REPORTS OF THE SYSTEM FAULTING WHEN INITIALLY POWERED ON.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1453547 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-31 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DA VINCI INSTRUMENTS AND ACCESSORIES