BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1221626 · Received November 3, 2008

    Report

    Report Number
    2955842-2008-01350
    Event Type
    Other
    Date Received
    November 3, 2008
    Date of Event
    October 9, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION BY THE FIELD SERVICE ENGINEER CONFIRMED WITH THE CUSTOMER REPORTED PROBLEM WAS 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 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 STARTING A DA VINCI S SURGICAL PROCEDURE, THE SITE EXPERIENCED A BLUE AND PURPLE TINT IN THE LEFT EYE OF THE HIGH RESOLUTION STEREO VIEWER (HRSV). THE SITE ATTEMPTED TO TROUBLESHOOT THE PROBLEM WITHOUT SUCCESS. THE PATIENT WAS UNDER ANESTHESIA AND PORT INCISIONS HAD BEEN CREATED BEFORE THE SITE DECIDED TO COMPLETE THE PROCEDURE USING A BACK UP DA VINCI SURGICAL SYSTEM. THE SURGICAL DELAY WAS APPROXIMATELY 45 MINUTES, WHILE THE SURGICAL STAFF PREPARED THE SECOND DA VINCI SYSTEM FOR SURGERY. NO PATIENT HARM, ADVERSE OUTCOME INJURY WAS REPORTED.

    Devices

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

    Patients

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