BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI XI SURGICAL SYSTEM

    MDR report key: 6679827 · Received June 29, 2017

    Report

    Report Number
    2955842-2017-00410
    Event Type
    Malfunction
    Date Received
    June 29, 2017
    Date of Event
    May 15, 2017
    Report Date
    May 15, 2017
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC (ISI) RECEIVED PMSC BOARD INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS CONFIRMED THE CUSTOMER REPORTED FAILURE. THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) BOARD FAILED AND DISPLAYED ERROR 48200 UPON THE FIRST START-UP. THE PMSC BOARD AND TWO SURGEON CONSOLE LEAF (SCL) BOARDS WERE REPLACED TO CORRECT THE ISSUE. SCL CARRY THE VIDEO OUTPUT CONNECTORS VISIBLE ON THE OUTSIDE OF THE PERSONALITY MODULES. THIS COMPLAINT IS BEING REPORTED DUE TO A DA VINCI SURGICAL 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 SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED AN ISSUE WITH THE LEFT VIDEO OUT ON THE SURGEON'S SIDE CONSOLE. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ADVISED THE CUSTOMER TO REBOOT THE DA VINCI SYSTEM, HOWEVER THE ISSUE CONTINUED TO OCCUR. THE CUSTOMER REPLACED THE ENDOSCOPE TWICE WITH NO CHANGE. AT THIS TIME THE CUSTOMER DECIDED TO SWITCH TO ANOTHER SURGEON'S SIDE CONSOLE TO COMPLETE THE PLANNED SURGICAL PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY. AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE FACILITY AND WAS ABLE TO REPRODUCE THE REPORTED FAILURE. THE FSE REPLACED THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) TO RESOLVE THE ISSUE. THE PMSC PROCESSES AUDIO AND VIDEO FROM THE SURGEON CONSOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459858 DA VINCI XI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS4000.A70P5D

    Patients

    Seq Age Sex Outcome Treatment
    1