Surgical 3D Imaging Guide System Recalled Due to Software Problems That May Cause Brain Damage, Death
Certain three-dimensional (3D) brain imaging systems used during surgical procedures are being recalled, due to a software defect that may prevent surgeons from accurately seeing tools in a patient while undergoing brain surgery, leading to an increased risk of serious injury or death.
The FDA announced a BrightMatter Guide System recall on November 30, indicating that physicians should not to switch the device’s configurations during use, as this may trigger a software defect that prevents the display feature.
The Synaptive Medical’s BrightMatter Guide with SurfaceTrace Registration is a device designed to capture 3D images of a patient’s brain. The devices are equipped with software that allows surgeons to switch between two configurations while capturing 3D images inside of a patient’s brain.
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According to the recall notice, surgeons and other trained medical professionals could experience a software defect when toggling between the two software configurations during use, which may result in the systems screen display failing. In this event, the surgeon would be forced to blindly navigating the 3D imaging tools, potentially resulting in damage to the patient’s brain and vascular structures.
The FDA has given the recall Class I status, indicating that the agency believes the software problems could result in serious patient injury or death.
FDA officials sent a Synaptive Medical letter in early October alerting trained medical professionals to verify the virtual tip offset valve displayed on the user display interface matches the obturator tip for the BrainPath ports, and to continually check this throughout procedures.
In the event these offset values are different, officials are asking medical professionals to verify the correct offset and adjust the setting for the BrainPath ports. Accuracy of each tool on anatomical landmarks should be checked continually during procedures until a patch is available to fix the software glitch.
FDA officials also issued a statement on November 16, instructing surgeons and operating room representatives not to switch between blue and gold ports until the software patch is available.
Synaptive Medical Inc. manufactured the recalled systems from November 17, 2017 through April 24, 2018. They were distributed to licensed medical professionals and medical centers up until July 2018.
To date, a schedule for the software update has not been made readily available. Customers are being encouraged to contact their Synaptive Medical Clinical Support Staff for additional questions and information.
Healthcare professionals and patients who suffer adverse events due to problems with the BrightMatter system are encouraged to report the incidents to the FDA’s MedWatch adverse event reporting program.
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