BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI S

    MDR report key: 8407383 · Received March 11, 2019

    Report

    Report Number
    2955842-2019-10179
    Event Type
    Malfunction
    Date Received
    March 11, 2019
    Date of Event
    February 11, 2019
    Report Date
    February 11, 2019
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K063220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING SECTIONS: DATE OF REPORT, CONCOMITANT MEDICAL PRODUCTS , PMA/510K, AND IF FOLLOW-UP, WHAT TYPE. (B)(4) - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE POWER SUPPLY INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION CONFIRMED THE REPORTED ISSUE. VISUAL INSPECTION OF THE UNIT FOUND A BENT METAL CHASSIS. THE POWER SUPPLY WAS UNABLE TO BE INSTALLED INTO THE TEST SYSTEM FOR VERIFICATION OF THE FAILURE DUE TO A BROKEN SWITCH. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    REFER TOADDITIONAL FOR FOLLOW-UP INFORMATION.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE POWER SUPPLY FOR FAILURE ANALYSIS. DEVICE EVALUATION IS ANTICIPATED BUT NOT YET BEGUN. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 PRIOR TO STARTING A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE, THE CUSTOMER DID NOT HAVE VIDEO ON HIGH RESOLUTION STEREO VIEWER (HRSV). THE SETTINGS WERE CHECKED, LED WAS NOT LIT FOR ENDOSCOPE ANGLE AND THE SELECTION BUTTON WAS NOT RESPONDING. ON TOUCHSCREEN, BOTH EYES WERE OKAY BUT NOT ON SURGEON SIDE CONSOLE (SSC) WHICH HAD BOTH EYES BLACK WITHOUT ICONS. A EMERGENCY POWER OFF (EPO) WAS PERFORMED ON THE SSC AND A RESTART ON THE SYSTEM BUT THE ISSUE PERSISTED. WHILE PERFORMING TROUBLESHOOTING, THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO LAPAROSCOPY. ANOTHER EPO AND RESTART WAS PERFORMED BUT THE HRSV WAS COMPLETELY BLACK, NO ICONS AND NO INITIALIZATION MESSAGE. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING INFORMATION FROM THE SITE ABOUT THE COMPLAINT: THE SYSTEM WAS INSPECTED AND CHECKED PRIOR TO STARTING; THE ISSUE PRESENTED AT THE BEGINNING OF THE PROCEDURE UPON INSERTION OF THE INSTRUMENTS (PORTS HAD ALREADY BEEN PLACED).THE SURGERY WAS ABLE TO BE COMPLETED WITH TRADITIONAL LAPAROSCOPY. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT. THE PATIENT IS DOING WELL. AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE REPORTED COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION. THE FSE REPLACED THE POWER SUPPLY TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202983 DA VINCI S SURGEON SIDE CONSOLE NAY INTUITIVE SURGICAL, INC 380429-03

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI INSTRUMENTS AND ACCESSORIES