StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedures using optical localization StealthStation Cranial version 3.0, 3.1 CE 0344 Rx Only 2018-02 9735489 Revision 3 Medtronic Navigation, Inc. Biopsy Needle Kit (9733068) Note: This device is an accessory to your StealthStation System. . . The Biopsy Needle is a presterilized , single-use, side-cutting needle for cranial tissue biopsies. CE 0344 Rx Only 2017-05 9733068-01 Medtronic Navigation, Inc.

An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial software, which resulted in the biopsy of healthy tissue.

On 09/26/2018, the firm sent an Urgent Medical Device Correction Notification to all US customers informing them of potential inaccuracy during biopsy procedures using the StealthStation S7 Depth Gauge feature on StealthStation S7 and i7 systems running Synergy Cranial and StealthStation Cranial software that could result in healthy tissue being biopsied. The notification letter stated, 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. Since 2011, Medtronic has received seven (7) complaints potentially related to this software anomaly, one in which healthy tissue was biopsied. The image on page two contains an example of the error use case. All views correctly show that the instrument is past the target, and the Depth Gauge correctly displays the past-target measurement of -63, which indicates the instrument tip has advanced 63 mm beyond the intended target. However, the graphical Biopsy Needle cut window appears not to have advanced to the target position. If the surgical team relies solely on the graphical representation in the Biopsy Depth Gauge feature and disregards other factors (such as