BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI X

    MDR report key: 18665127 · Received February 7, 2024

    Report

    Report Number
    2955842-2024-11137
    Event Type
    Malfunction
    Date Received
    February 7, 2024
    Date of Event
    January 17, 2024
    Report Date
    March 20, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INTUITIVE SURGICAL INC. (ISI) FIELD SERVICE ENGINEER (FSE) REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE . THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE UNIVERSAL SURGICAL MANIPULATOR (USM) INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE REPORTED ISSUE WAS CONFIRMED AND REPLICATED. THE USM WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE, AND IT FAILED THE BACK DRIVE TEST WITH THE YAW BEING NOTED AS NOISY. THE USM WAS TESTED ON A TEST PLATFORM AND FAILED THE YAW CHIP ENCODER VIRTUAL ABSOLUTE (CVA) CHARACTERIZATION. THE YAW CVA FLAT FLEX CABLE (FFC) WAS REPLACED WITH A GOLD FFC AND THE USM PASSED THE CVA CHARACTERIZATION TEST. THE YAW CVA FFC WILL BE REPLACED AS A FIX.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, A CUSTOMER REPORTED THAT DURING USE SOMETIMES, THE UNIVERSAL SURGICAL MANIPULATOR (USM) 3 MOVEMENT SEAMED LIKE IT WAS PHYSICALLY BLOCKED, ESPECIALLY WHEN MOVING IT FROM THE SURGEON SIDE CART (SSC). THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809642 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-33 N/A 00886874115404

    Patients

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