BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 9101427 · Received September 22, 2019

    Report

    Report Number
    2955842-2019-10737
    Event Type
    Malfunction
    Date Received
    September 22, 2019
    Date of Event
    September 4, 2019
    Report Date
    October 19, 2019
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    4307- INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HIGH RESOLUTION STEREO VIEWER (HRSV) ASSOCIATED WITH THIS COMPLAINT AND COMPLETED ITS INVESTIGATION. FAILURE ANALYSIS (FA) CONFIRMED THE REPORTED ISSUE ¿ LEFT EYE HAS NO VISION. FA FOUND THAT THE HRSV HAS NO VIDEO. THE VIDEO ON THE UNIT WAS REPAIRED AND CALIBRATED TO MEET ISI SPECIFICATIONS. ISI RECEIVED THE SECOND HIGH RESOLUTION STEREO VIEWER (HRSV) ASSOCIATED WITH THIS COMPLAINT AND COMPLETED ITS INVESTIGATION. FAILURE ANALYSIS (FA) DID NOT CONFIRM THE REPORTED ISSUE ¿ LEFT EYE HAS NO VISION. FA FOUND NO PROBLEM WITH THE HRSV. PREVENTATIVE MAINTENANCE WAS COMPLETED AND THE UNIT WAS CLEANED, TESTED, BURNED-IN AND ALL FUNCTIONS WERE CHECKED TO MEET ISI SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    11 - INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERSONALITY MODULE SURGEON CONSOLE (PMSC) ASSOCIATED WITH THIS COMPLAINT AND COMPLETED ITS INVESTIGATION. FAILURE ANALYSIS (FA) CONFIRMED THE REPORTED ISSUE ¿ LEFT EYE HAS NO VISION. THE PMSC WAS INSTALLED INTO THE TEST SYSTEM AND FAILED VIDEO TEST. THE LEFT IMAGE WAS LOST AND TROUBLESHOOTING DETERMINED THAT THE SURGEON CONSOLE LEAF (SCL) 1 WAS THE CAUSE OF THE ISSUE. FAILURE ANALYSIS OF THE HIGH RESOLUTION STEREO VIEWERS (HRSV) MONITOR HAS NOT YET BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. FSE REPRODUCED THE REPORTED ISSUE ¿ LEFT EYE HAS NO VISION. THE FSE REPLACED THE HIGH RESOLUTION STEREO VIEWERS (HRSV) AND PERSONALITY MODULE SURGEON CONSOLE (PMSC) TO RESOLVE LEFT EYE VIDEO LOSS ISSUE. FOLLOWING SERVICE, THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE HRSV AND PMSC WERE RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION. HOWEVER, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED AS FAILURE ANALYSIS INVESTIGATION IS IN PROGRESS. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: SYSTEM UNAVAILABILITY AFTER START OF A SURGICAL PROCEDURE (FIRST PORT INCISION) COULD LEAD TO THE PROCEDURE TO BE CONVERTED/ABORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A TOTAL BENIGN HYSTERECTOMY PROCEDURE THE LEFT EYE OF THE SURGEON CONSOLE WAS OUT. TECHNICAL SUPPORT HAD THE CUSTOMER REMOVE INSTRUMENTS, CYCLE SYSTEM POWER AND SURGEON CONSOLE CIRCUIT BREAKER, BUT THE LEFT EYE WAS STILL OUT AFTER THE SYSTEM POWERED UP AND HOMED. THE SITE SWAPPED TO A NEW ENDOSCOPE, RESEATED BLUE FIBERS AND HARD CYCLED THE SYSTEM, BUT THE ISSUE WITH THE LEFT EYE PERSISTED. THE SITE COMPLETED THE PROCEDURE AND THERE WAS NO REPORTED PATIENT INJURY NOR HARM. INTUITIVE FOLLOWED UP WITH THE SITE AND CONFIRMED THAT THE OPERATING ROOM (OR) STAFF EXHAUSTED ALL TROUBLESHOOTING STEPS WITH TECHNICAL SUPPORT. THE SITE COMPLETED THE PROCEDURE WITH ONE EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896107 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-03

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI INSTRUMENTS AND ACCESSORIES