BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI XI SURGICAL SYSTEM

    MDR report key: 6825714 · Received August 28, 2017

    Report

    Report Number
    2955842-2017-00576
    Event Type
    Malfunction
    Date Received
    August 28, 2017
    Date of Event
    August 8, 2017
    Report Date
    August 8, 2017
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ISI RECEIVED THE DEVICES INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATIONS. THE VP WAS INSTALLED IN THE TEST SYSTEM AND THE PROBLEM WAS VERIFIED. THE VP CAME UP WITH NO ERRORS AND GOOD VIDEO ON BOTH EYES WITH NO ANOMALIES; HOWEVER, AFTER A FEW MINUTES SITTING IDLE THE SYSTEM THREW THE 307 ERROR CODE ON ALL OF THE EC AND VP NODES. DWA NODES WERE MISSING IN GDLA. THE DWA NEEDS TO BE REPLACED TO CORRECT THE PROBLEM. THIS EC WAS RETURNED FOR ERROR CODE 307 WHICH INDICATES THAT A NODE CONFIGURED TO BE PRESENT DID NOT RESPOND. THE EC WAS INSTALLED IN THE TEST SYSTEM AND THE REPORTED PROBLEM COULD NOT BE REPLICATED. THE EC CAME UP WITH NO ERRORS AND GOOD VIDEO ON BOTH EYES WITH NO ANOMALIES. THE SYSTEM RAN 20 POWER CYCLES WITH THIS EC WITH NO ERRORS AND NO VIDEO ISSUES. 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 PROSTATECTOMY PROCEDURE, THE CUSTOMER EXPERIENCED A NON-RECOVERABLE ERROR 307. THE CUSTOMER ATTEMPTED TO TROUBLESHOOT BY REMOVING THE INSTRUMENTS AND POWER CYCLING THE SYSTEM, HOWEVER, UPON POWER UP THE SYSTEM FAULTED ONCE AGAIN. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ALSO ATTEMPTED TROUBLESHOOTING AND WAS ABLE TO RECOVER FROM THE FAULT AND THE CUSTOMER CONTINUED WITH THE PROCEDURE. HOWEVER, THE CUSTOMER CALLED BACK TO REPORT THAT THE SYSTEM AGAIN GENERATED THE NON-RECOVERABLE ERROR 307. THE TSE ONCE AGAIN PERFORMED TROUBLESHOOTING AND WAS ABLE TO RECOVER THE FAULT. HOWEVER, AT THAT TIME THE CUSTOMER MADE THE DECISION TO CONTINUE AND COMPLETE THE PROCEDURE USING ANOTHER DAVICI SYSTEM. THERE WAS NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY. AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE FACILITY BUT WAS NOT ABLE TO REPRODUCE THE REPORTED FAILURE; HOWEVER, THE FSE DID CONFIRM THE ERRORS IN THE SYSTEM LOGS. THE FSE REPLACED THE ENDOSCOPE CONTROLLER (EC), THE VIDEO PROCESSOR (VP), THE FIBER CABLES FROM THE EC TO THE VP AND CABLE FROM THE CORE TO THE VP. THE EC CONTAINS A HIGH-INTENSITY LIGHT SOURCE TO ILLUMINATE THE SURGICAL SITE AND THE ELECTRONICS FOR INITIAL PROCESSING OF ENDOSCOPIC VIDEO. THE VP PROCESSES THE VIDEO STREAM FROM THE ENDOSCOPE AND PROVIDES A USB PORT FOR IMAGE RECORDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605016 DA VINCI XI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS4000 A70P6B

    Patients

    Seq Age Sex Outcome Treatment
    1