BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 16971319 · Received May 21, 2023

    Report

    Report Number
    2955842-2023-13967
    Event Type
    Malfunction
    Date Received
    May 21, 2023
    Date of Event
    March 11, 2020
    Report Date
    March 11, 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
    NM, US
    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. FE REPLACED USM4 TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED THE PARTS INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION COULD NOT BE REPRODUCE THE REPORTED FAILURE. HOWEVER, THE ERROR/FAULT WAS CONFIRMED VIA ERROR LOGS/SYSTEM LOGS. THE UNIT WAS ABLE TO START IN NORMAL MODE AND THROUGH DTE PRE-FA TESTING WITH NO ERRORS. ALL COMMON CONNECTIONS ON ACA AND FCP WERE CHECKED AND LOOKED OK. THE ACA, FCP PCA AND HARNESS ASSY WILL BE REPLACED AS A PRECAUTION. THE UNIT WAS TESTED ON PATIENT SIDE CART FIXTURE TEST PLATFORM (PFTP) AND PASS DIRECTION, LISSAJOUS, CHECK SENSORS, BRAKE RELEASE, BRAKE HOLD, ADVANCE BRAKE, CARRIAGE SWITCHES AND SINE CYCLE TESTS.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A DA VINCI-ASSISTED UMBILICAL HERNIA REPAIR SURGICAL PROCEDURE, THE USER ENCOUNTERED A NON-RECOVERABLE 319 ERROR ON ARM 4. AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED AND NOTED THE SURGICAL STAFF DISABLED THE ARM AND COMPLETED THE PROCEDURE AS PLANNED. THERE WAS NO REPORTED PATIENT INJURY NOR HARM. ON SITE LOGS WERE REVIEWED AND THERE WAS AN ERROR 319, WHICH POINTS TO THE UNIVERSAL SURGICAL MANIPULATOR (USM) 4. THERE WAS REPORTED PATIENT INJURY NOR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507504 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-38 N/A 00886874110720

    Patients

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