Health Canada — Medical Devices · Canada · 2018-11-02 · Type II
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Reported risk: The purpose of this notification is to provide information related to potential inaccuracy during biopsy procedures using the StealthStation S7 depth gauge feature in navigated biopsy procedures, where the "navigate projection" feature is used and the projection is longer than the length of the plan, the graphical biopsy depth gauge feature can display inaccurate information. The biopsy needle depth gauge is a numerical and graphical representation of the needle cutting window in the guidance view quadrant to assist in visualization of the cutting window position. During a biopsy procedure, the monitor shows four quadrants (trajectory 1, trajectory 2, guidance, and probe's eye views) as well as the biopsy depth gauge. The overlay of the biopsy needle within the anatomical views accurately indicates the correct tip location of the instrument. However, if "navigate projection" is selected, and the projection is longer than the length of the plan, then the biopsy depth gauge graphical display inaccurately depicts that the tip of the instrument has not yet reached the plan target.
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