BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI

    MDR report key: 10905503 · Received November 25, 2020

    Report

    Report Number
    2955842-2020-11271
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    November 2, 2020
    Report Date
    November 2, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110874
    PMA / PMN Number
    K081137
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE REPLACED THE DOUBLE CAMERA CONTROLLER (DOCO) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE UNIT WAS RETURNED FOR FAILURE ANALYSIS, BUT THE REPORTED FAILURE COULD NOT BE REPLICATED, NOR CONFIRMED. THE DOCO WAS INSTALLED ONTO THE TEST SYSTEM, WHERE IT RAN THROUGH 10 POWER CYCLES AND SAT IDLE FOR ONE HOUR. THE UNIT SUCCESSFULLY CALIBRATED FOR WHITE BALANCE AND 3D IMAGE. THE ZOOM FUNCTION WORKED WITH NO ISSUE. THERE WAS NO TROUBLE FOUND WITH THE UNIT. SITE HISTORY REVIEW: A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. IMAGE/VIDEO REVIEW: NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. BASED ON THE INFORMATION PROVIDED AT THIS TIME, THIS COMPLAINT IS BEING CLASSIFIED AS A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: THE LEVEL OF ZOOM AND FIELD OF VIEW WAS INSUFFICIENT WITH THE ORIGINAL VISION SIDE CART (VSC), LEADING THE SITE TO CONVERT THE PROCEDURE TO ANOTHER VSC TO RESOLVE THE VISION ISSUE. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED TO REPORT THAT THE CAMERA ZOOM WAS NOT WORKING FROM THE SURGEON CONSOLE. OPERATING ROOM STAFF STATED THEY CYCLED SYSTEM POWER AND SWAPPED TO BACK UP CAMERA AND BACK UP CAMERA CABLE, BUT THE ZOOM WAS STILL NOT WORKING. THE CUSTOMER CONTACTED TECHNICAL SUPPORT FOR TROUBLESHOOTING ASSISTANCE. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) ASKED THE OR STAFF TO TRY ADJUSTING ZOOM MANUALLY FROM SURGEON CONSOLE TOUCHPAD MENU SETTINGS AND OR STAFF STATED ZOOM WAS WORKING FROM TOUCHPAD SETTINGS. SURGEON CONTINUED WITH CASE. CUSTOMER CALLED BACK AS THE SURGEON COMPLAINED THAT THE FIELD OF VIEW WAS NOT FULL ENOUGH. OR STAFF WAS GOING TO TRY AND GET ANOTHER SURGEON CONSOLE TO TRY. IF OR STAFF IS UNABLE TO FIND ANOTHER SURGEON CONSOLE, SURGEON WILL HAVE TO CONVERT TO OPEN PROCEDURE. CUSTOMER CALLED IN AGAIN ASKING IF THEY COULD BRING IN ANOTHER SURGEON SIDE CONSOLE (SSC) TO SEE IF THAT WOULD WORK. TSE ADVISED CUSTOMER TO POWER DOWN THE SYSTEM BEFORE INTRODUCING THE NEW SSC. OR STAFF BROUGHT IN ANOTHER VISION CART, AND THE ZOOM AND FIELD OF VIEW WAS GOOD ON NEW VISION CART. SURGEON WAS CONTINUING WITH CASE ROBOTICALLY. THE PROCEDURE WAS CONVERTED TO ANOTHER VSC AND THERE WAS NO REPORTED INJURY. ISI FOLLOWED UP WITH THE REPORTER AND OBTAINED THE FOLLOWING INFORMATION: THE CAMERA ZOOM COULD NOT BE CONTROLLED USING THE SURGEON CONSOLE TOUCHPAD. THE SITE SWAPPED THE SURGEON'S CONSOLE BUT THE ISSUE WAS PERSISTENT. SUBSEQUENTLY, THE STAFF SWAPPED OUT THE VISION SIDE CART AND THE ZOOM ISSUE WAS RESOLVED. THERE WERE NO ERRORS RECEIVED BY THE SYSTEM. THE PROCEDURE WAS COMPLETED ROBOTICALLY WITH NO INJURY TO THE PATIENT. PATIENT-RELATED INFORMATION WAS REQUESTED BUT WAS NOT ABLE TO BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369292 DAVINCI SI VISION SIDE SYSTEM NAY INTUITIVE SURGICAL, INC 380990-16 N/A 00886874110874

    Patients

    Seq Age Sex Outcome Treatment
    1