Medical device manufacturer, Medtronic, issued a medical device safety alert concerning its Synergy Cranial (9733763) [Version 2.2.8] and StealthStation Cranial (9735585) [Versions 3.1.1, 3.1.2, and 3.1.3].
The manufacturer has received a complaint that during navigation in a Cranial Biopsy Procedure, the user may encounter an anomaly with the Biopsy Depth Gauge graphical display in the software. The software can enter a state where the Biopsy Depth Gauge is no longer synchronized with the rest of the navigational information on the screen and displays an inaccurate position of the biopsy needle.
According to the manufacturer, if the user encounters the software anomaly where the graphical Biopsy Depth Gauge is no longer synchronized with other navigation views, there is the potential to navigate the biopsy needle too shallow or deep to target. This issue can potentially lead to resection of normal brain tissue or eloquent anatomical regions of the brain. When this software anomaly is encountered, it may result in a prolonged procedure, the need for an additional surgical procedure, tissue injury, including potential for life-threatening injury (hemorrhage, unintended tissue damage, permanent neurological injury), which could lead to death.
The manufacturer will provide a warning and instructional placard to be applied to impacted systems to maintain visibility to the mitigations until a software fix is available.
According to the local supplier, the affected devices are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 18 Nov 2021