3D visualization firm Synaptive Medical has recalled three versions of its BrightMatter Guide surgical navigation software due to a software defect that could lead to serious or life-threatening harm, according to the U.S. Food and Drug Administration (FDA).
On October 9, Synaptive initiated a recall of versions 1.50, 1.51, and 1.52 of its BrightMatter Guide with SurfaceTrace Registration system, which is designed to provide 3D brain images to help surgeons navigate surgical tools used during brain surgery, according to the FDA. The company had identified a software defect for BrightMatter Guide when it was used with two configurations of the Nico BrainPath device -- a third-party port. Upon switching between the two configurations, a software defect may be triggered that affects the system's display and prevents the surgeon from being able to accurately see the location of surgical tools in the brain, the FDA said.
"In the event this software defect occurs, the surgeon could potentially damage the patient's brain and vascular structures," the FDA said in a medical device recall announcement.
The agency said it has identified this action as a class I recall -- the most serious type. A total of 36 devices were recalled in the U.S.
In its October 9 letter to customers, Synaptive directed users to take the following steps:
- Check that the virtual tip offset value displayed on the user display interface matches the obturator tip for the BrainPath ports.
- Continue to check the offset value periodically throughout the procedure.
- If an incorrect tip offset value is being displayed on the user interface, do the following:
- Adjust the offset for the BrainPath ports to the correct value.
- Verify the offset value with the surgeon as being the correct and intended offset.
- Check the accuracy of each tool on anatomical landmarks before using for navigation purposes.
- Continue checking accuracy of the tool periodically throughout the procedure.
- Continue the verification actions listed above until the firm issues a patch to fix the software defect.
Synaptive also notified its operating room representatives on November 16 to instruct all users not to switch between blue and gold ports until the software patch has been adequately applied, the FDA said.