BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 18098585 · Received November 9, 2023

    Report

    Report Number
    2955842-2023-20044
    Event Type
    Malfunction
    Date Received
    November 9, 2023
    Date of Event
    October 16, 2023
    Report Date
    October 16, 2023
    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
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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 EVENT. THE ISI FSE REPLACED USM 2 ON THE PATIENT SIDE CART (PSC) DUE TO 32100 ERRORS. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM A FAILURE ANALYSIS. THE USM FAILURE ANALYSIS WITH A REPORTED PROBLEM OF ERROR 32100 WHICH WAS CONFIRMED AS HAVING OCCURRED IN THE FIELD AND REPLICATED. THE UNIT WAS TESTED ON AN IN-HOUSE SYSTEM IN NORMAL MODE WHERE IT TRIGGERED ERROR 32100. THE UNIT WAS ALSO TESTED ON A PFTP WHERE IT FAILED THE DIRECTION TEST ON THE PITCH. THE TROUBLESHOOTING WAS DONE WITH A GOLD PITCH MOTOR MODULE INSTALLED TO VERIFY FAILURE. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER-REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED WHILE SETTING UP FOR THE PROCEDURE THAT AN ERROR 32100 WAS REPEATEDLY ON ARM 2. THE SYSTEM LOGS CONFIRMED THE ARM CONTROLLER BRAKE ERROR REPORTED BY THE UNIVERSAL SURGICAL MANIPULATOR (USM) 2 AXES CONTROLLER ARM (ACA). INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) ADVISED SELECTING ARM DISABLE. AFTER DISABLING THE ARM, THE CUSTOMER RECOVERED FROM THE FAULT AND THE SYSTEM WAS FUNCTIONAL WITH THE THREE REMAINING ARMS. THE PROCEDURE OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75441 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-56 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 Male DA VINCI INSTRUMENTS AND ACCESSORIES.