BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 1123768 · Received August 18, 2008

    Report

    Report Number
    2955842-2008-01213
    Event Type
    Other
    Date Received
    August 18, 2008
    Date of Event
    July 22, 2008
    Report Date
    August 15, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY FIELD SERVICE ENGINEERING CONFIRMED THAT UNEXPECTED SET UP JOINT MOVEMENT EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH THE ENDOSCOPIC CAMERA MANIPULATOR (ECM). THE ECM IS THE CAMERA ARM LOCATED ON THE PT SIDE CART WHICH PROVIDES THE STERILE INTERFACE FOR THE 3D ENDOSCOPE. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED ECM. THE FIELD SERVICE ENGINEER PERFORMED A CLUTCH MOVE OF THE ECM SET UP JOINT WHICH CLEARED THE SYSTEM ERROR MESSAGE. 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 DURING A DA VINCI SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED UNEXPECTED SET UP JOINT MOVEMENT ON THE ENDOSCOPIC CAMERA MANIPULATOR (ECM) ARM. AN ISI TECHNICAL SUPPORT ENGINEER ATTEMPTED TO ASSIST THE CUSTOMER, HOWEVER, THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO TRADITIONAL OPEN SURGICAL TECHNIQUE TO COMPLETE THE PLANNED PROCEDURE. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL, INC. ISI200 A4.3PL

    Patients

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