BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18567144 · Received January 23, 2024

    Report

    Report Number
    2955842-2024-10449
    Event Type
    Malfunction
    Date Received
    January 23, 2024
    Date of Event
    January 2, 2024
    Report Date
    January 2, 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
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE UNIVERSAL SURGICAL MANIPULATOR (USM) AND COMPLETED THE FAILURE ANALYSIS. THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS ANALYZED, AND FAILURE ANALYSIS INVESTIGATION REPLICATED THE REPORTED ISSUE. THE USM WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE AND HAD ERROR 23096. THE USM WAS ALSO FOUND TO FAIL THE CHIPENCODER VIRTUAL ABSOLUTE (CVA) CHARACTERIZATION ON THE INSERTION WITH ERROR 23065. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    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 WAS ABLE TO REPLICATE THE REPORTED ISSUE AFTER TURNING THE SYSTEM ON. THE FSE REPLACED THE USM TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO HAVE THE INTUITIVE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE PRODUCT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE PORTS WERE PLACED WHEN THE REPORTED ISSUE OCCURRED. THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON THE SYSTEM. THE SYSTEM POWERED ON WITH NO ERRORS.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, REPEATED ERRORS OCCURRED AGAINST UNIVERSAL SURGICAL MANIPULATOR 3 (USM). THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) REPORTING THE ISSUE EMAILED THE SYSTEM LOG IMAGES TO THE ISI TECHNICAL SERVICE ENGINEER (TSE). THE LOGS INDICATED A FAILURE OF USM 3 AXIS 3. THE CUSTOMER DISABLED USM 3 TO CONTINUE THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1649073 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-56 N/A 00886874110720

    Patients

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