BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1353511 · Received March 20, 2009

    Report

    Report Number
    2955842-2009-00114
    Event Type
    Other
    Date Received
    March 20, 2009
    Date of Event
    February 25, 2008
    Report Date
    February 25, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER FOUND THE CUSTOMER REPORTED PROBLEM TO BE ASSOCIATED WITH THE DIGITIZER. 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 DIGITIZER. AS OF MARCH 20, 2009, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S SURGICAL PROCEDURE, THE SITE EXPERIENCED A LOSS OF VISION ON THE RIGHT VIDEO OF THE HIGH RESOLUTION STEREO VIEWER (HRSV). THE 2D SIGNAL WAS ON AND THE LED INDICATOR WAS LIT. THE SURGEON DECIDED TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. NO PATIENT HARM 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 A5.1P7

    Patients

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