BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16971345 · Received May 21, 2023

    Report

    Report Number
    2955842-2023-13988
    Event Type
    Malfunction
    Date Received
    May 21, 2023
    Date of Event
    May 29, 2020
    Report Date
    May 29, 2020
    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
    IT
    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 COMPLAINT. THE FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE USM INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED AND REPLICATED THE CUSTOMER REPORTED COMPLAINT. THE USM FAILED THE NORMAL MODE ON THE SYSTEM AND TRIGGERED 23065 ERROR POINTING TO DEGREE OF FREEDOM (DOF) 5 STATOR. RESEATED THE DOF 5 STATOR AND DID NOT FIX THE ISSUE. SWAPPED THE DOF 5 STATOR WITH A TEST ONE AND FIXED THE 23062 ERROR. THE ORIGINAL DOF 5 STATOR WAS INSTALLED, AND THE 23062 ERROR OCCURRED AGAIN. AS A FIX, THE DOF 5 STATOR WAS REPLACED AND AS A PRECAUTION, THE AXES CONTROLLER, CARRIAGE POWER (ACCP) PRINTED CIRCUIT ASSEMBLY (PCA) WAS REPLACED TO ADDRESS THE REPORTED PROBLEM. THE USM WAS ALSO TESTED ON THE IN-HOUSE SYSTEM WITH THE TEST DOF 5 STATOR AND PASSED DIRECTION TEST, LISSAJOUS , SENSOR CHECK, SINE CYCLE, BRAKE TESTS, AND CARRIAGE SWITCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYSTEM REFLECTED ERROR 23062 ON THE UNIVERSAL SURGICAL MANIPULATOR (USM4). THE USM WAS DISABLED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478320 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-40 N/A 00886874110720

    Patients

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