BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMERA CORD

    MDR report key: 2973634 · Received February 14, 2013

    Report

    Report Number
    2973634
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 14, 2013
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    DURING THE ROBOTIC HYSTERECTOMY AFTER THE PORT WAS INSERTED AND THE GAS WAS INSTILLED INTO THE ABDOMEN, THE CAMERA FAILED TO ALLOW 3-D IMAGING. THE STAFF WAS UNABLE TO FIX THE ISSUE. THE ROBOTIC APPROACH WAS ABORTED. THE SURGEON ELECTED TO PERFORM AN OPEN ABDOMINAL HYSTERECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66302 CAMERA CORD SYSTEM, SURGICAL, COMPUTER CONTROLLED, CAMERA CORD NAY INTUITIVE SURGICAL, INC. * *
    66303 CAMERA CORD SYSTEM, SURGICAL, COMPUTER CONTROLLED, CAMERA CORD NAY INTUITIVE SURGICAL, INC. * *
    66304 * ---

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR