BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI XI SURGICAL SYSTEM

    MDR report key: 6436154 · Received March 27, 2017

    Report

    Report Number
    2955842-2017-00178
    Event Type
    Malfunction
    Date Received
    March 27, 2017
    Date of Event
    March 2, 2017
    Report Date
    March 2, 2017
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ISI RECEIVED THE DEVICE INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS WAS ABLE TO CONFIRM THE CUSTOMER REPORTED FAILURE MODE. THE COVER OF THE EC WAS REMOVED AND IT WAS DISCOVERED THAT THE SFP TRANSCEIVER MODULE WAS DISLODGED FROM ITS CAGE ON THE DCIB BOARD. THE SFP MODULE WAS INSTALLED INTO THE CAGE. THEN THE EC WAS INSTALLED AND TESTED ON AN IN-HOUSE TEST SYSTEM AND THERE WERE NO ERRORS GENERATED AND VIDEO ISSUE WAS FIXED. THE SFP MODULE WAS NOT RETAINED BY THE LOCKING MECHANISM OF THE CAGE DUE TO A DEFECTIVE DCIB BOARD. THE DCIB BOARD WILL BE REPLACED TO CORRECT THE PROBLEM. 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 CHOLECYSTECTOMY PROCEDURE, THE CUSTOMER EXPERIENCED SEVERAL 319 NON-RECOVERABLE FAULTS. THE CUSTOMER ATTEMPTED TO REBOOT THE SYSTEM ONCE PRIOR TO CALLING THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT. THE CUSTOMER ALSO STATED THAT AN IMAGE MAY BE DEGRADED WARNING MESSAGE WAS OBSERVED ON THE SCREEN AND THEY DISCONNECTED THE SCOPE. FURTHER TROUBLESHOOTING WITH AN ISI TECHNICAL SPECIALIST ENGINEER (FSE) WAS PERFORMED BUT THE ISSUE PERSISTED; THE SYSTEM KEPT FAULTING WITH A 319 NON-RECOVERABLE ERROR ON ALL ARMS. THERE WAS NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY. ON 3/3/2017 ISI FOLLOWED UP WITH THE ISI CLINICAL SALES REPRESENTATIVE (CSR) AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CSR STATED THAT ONE PORT HAD BEEN PLACED ON THE PATIENT BUT NO INSTRUMENTS HAD BEEN INSTALLED AT THE TIME THE REPORTED ISSUE OCCURRED. FURTHERMORE, THE ISI TSE HAD ADVISED THE CUSTOMER TO PERFORM AN EMERGENCY POWER OFF OF THE PATIENT SIDE CART BUT ONCE AGAIN THE ISSUE PERSISTED. AT THAT TIME, THE CUSTOMER DECIDED TO COMPLETE THE PROCEDURE USING ANOTHER DA VINCI SYSTEM. AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE FACILITY AND WAS ABLE TO REPRODUCE THE REPORTED FAILURE. THE FSE REPLACED THE ENDOSCOPIC CONTROLLER (EC). 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
    219019 DA VINCI XI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS4000 A70P6

    Patients

    Seq Age Sex Outcome Treatment
    1