BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1221625 · Received November 3, 2008

    Report

    Report Number
    2955842-2008-01345
    Event Type
    Other
    Date Received
    November 3, 2008
    Date of Event
    October 6, 2008
    Report Date
    November 3, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION BY THE FIELD SERVICE ENGINEER CONFIRMED THE CUSTOMER REPORTED PROBLEM WAS ASSOCIATED WITH THE CAMERA CONTROL UNIT (CCU) AND THE DIGITIZER. THE CCU CALIBRATES AND ADJUSTS THE BRIGHTNESS LEVELS OF THE VIDEO IMAGE FROM THE TWO HIGH MAGNIFICATION CAMERA HEADS. THE CCU THEN FEEDS THE IMAGE THROUGH THE VIDEO SYNCHRONIZER TO THE SURGEON'S CONSOLE AND ASSISTANT MONITOR. THE DIGITIZER CONVERTS THE ANALOG VIDEO IMAGES RECORDED BY THE CAMERA INTO A DIGITAL FORMAT SO THAT IT CAN BE TRANSMITTED OVER THE FIBER-OPTIC CABLE AND COMBINED WITH OTHER IMAGES. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED CCU AND DIGITIZER. AS OF 2008, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO THE STARTING OF A DA VINCI S PROSTATECTOMY PROCEDURE, THE SITE EXPERIENCED THE LEFT AND RIGHT VIDEO TO BE OUT OF SYNCHRONIZATION. WITH THE HELP OF AN ISI TECHNICAL SUPPORT ENGINEER, THE SITE ATTEMPTED TO TROUBLESHOOT THE PROBLEM BY POWERING DOWN THE SYSTEM, RESEATING VISION CABLES, AND REDOING THE BLACK AND WHITE BALANCE WITHOUT SUCCESS. THE PATIENT WAS UNDER ANESTHESIA AND PORT INCISIONS HAD BEEN CREATED BEFORE THE SURGICAL STAFF MADE THE DECISION TO ABORT THE PROCEDURE. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL, INC. IS2000 A5.1P6

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ACCESSORIES| DA VINCI S SURGICAL SYSTEM INSTRUMENTS