BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 8776161 · Received July 10, 2019

    Report

    Report Number
    2955842-2019-10520
    Event Type
    Malfunction
    Date Received
    July 10, 2019
    Date of Event
    July 1, 2019
    Report Date
    July 1, 2019
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    4307 - INTUITIVE SURGICAL INC. (ISI) HAS RECEIVED THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) FOR FAILURE ANALYSIS INVESTIGATION. THE PMSC WAS INSTALLED ON THE TEST SYSTEM AND FAILED WITH ERROR 48200 ON STARTUP. SPECIFICALLY, THE LEAF ID COMPONENT ON THE PMSC HAD FAILED.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL INC. (ISI) HAS NOT RECEIVED THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) FOR FAILURE ANALYSIS INVESTIGATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA ONCE THE FAILURE ANALYSIS INVESTIGATION HAS BEEN COMPLETED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. THE COMPLAINT IS BEING REPORTED DUE TO A DA VINCI SYSTEM MALFUNCTION RENDING THE DA VINCI SYSTEM UNAVAILABLE FOR USE AFTER THE START OF A SURGICAL PROCEDURE. ALTHOUGH NO PATIENT HARM OCCURRED, IF THE REPORTED MALFUNCTIONED 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 THYMECTOMY SURGICAL PROCEDURE, THERE WAS NO IMAGE IN THE RIGHT EYE IN THE SURGEON SIDE CONSOLE (SSC). THERE WAS A 48200 ERROR. THE TECHNICAL SUPPORT ENGINEER (TSE) HAD THE CUSTOMER PERFORM A HARD POWER CYCLE OF THE SSC. THE IMAGE WAS NOT RESTORED AND THE ERROR RETURNED. THE CUSTOMER REPOSITIONED THE HIGH RESOLUTION STEREO VIEWER (HRSV) WITH NO CHANGE. THE CUSTOMER ALSO DISCONNECTED VIDEO OUTPUTS FROM THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) WITH NO RESOLVE. THE PROCEDURE WAS CONVERTED TO ANOTHER DV WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER TO CONFIRM THAT THE SYSTEM WAS POWERED ON PRIOR TO STARTING THE PROCEDURE AND THERE WERE NO ISSUES NOTED DURING SETUP. THE CUSTOMER BROUGHT IN ANOTHER SSC AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572047 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-05

    Patients

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