BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI XI SURGICAL SYSTEM

    MDR report key: 6996315 · Received November 2, 2017

    Report

    Report Number
    2955842-2017-00728
    Event Type
    Malfunction
    Date Received
    November 2, 2017
    Date of Event
    October 19, 2017
    Report Date
    October 19, 2017
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE UNIT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED THE CUSTOMER REPORTED FAILURE. THE EC WAS INSTALLED INTO A TEST SYSTEM AND IT FAILED TO POWER ON WITH ERROR 48238. THIS COMPLAINT IS BEING REPORTED DUE TO A DA VINCI SYSTEM MALFUNCTION RENDERING THE DA VINCI SYSTEM UNAVAILABLE FOR USE AFTER THE START OF A SURGICAL PROCEDURE. ALTHOUGH NO PATIENT HARM OCCURRED, IF THIS MALFUNCTION WERE TO RECUR IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DISTAL PANCREATECTOMY PROCEDURE, THE CUSTOMER RECEIVED A MESSAGE THAT THE SCOPES WERE NOT CONNECTING. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ADVISED THE CUSTOMER TO PERFORM A HARD POWER CYCLE OF THE VISION SIDE CART (VSC) BUT THE ISSUE PERSISTED. THE SURGEON CONVERTED THE PROCEDURE TO TRADITIONAL LAPAROSCOPIC SURGERY. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED. AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE FACILITY AND REPLACED THE ENDOSCOPE CONTROLLER (EC) TO RESOLVE THE ISSUE. THE EC CONTAINS A HIGH-INTENSITY LIGHT SOURCE TO ILLUMINATE THE SURGICAL SITE AND THE ELECTRONICS FOR INITIAL PROCESSING OF ENDOSCOPIC VIDEO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775169 DA VINCI XI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS4000 A70P6B

    Patients

    Seq Age Sex Outcome Treatment
    1