This is not the first time BrightMatter Guide with SurfaceTrace Registration has been recalled.
This photo has been altered. Photo licensed by kentoh - Fotolia.
(Editor's note: This story has been updated to reflect additional information provided by a Synaptive spokesperson.)
Med-tech company Synaptive Medical this fall recalled its BrightMatter Guide with SurfaceTrace Registration system due to a software defect that can cause serious injuries or death, an issue that it says has since been resolved.
The recall was identified as a Class I recall by the U.S. Food & Drug Administration (FDA), the most serious type of its kind.
BrightMatter Guide with SurfaceTrace Registration provides detailed 3D images of a patient’s brain to help surgeons safely navigate surgical tools used during brain surgery. The bug could have occurred if the device were used with a third-party port, the NICO BrainPath device, which would affect the system’s display and prevent the surgeon from accurately seeing the location of surgical tools in the patient’s brain.
>> READ: FDA Wants to Push Medical Device Makers to Innovate Beyond Old Predicates
If this defect occurs, a surgeon could damage the patient’s brain and vascular structures.
Synaptive initiated the recall and began notified providers on Oct. 9, but the problem was not posted publicly until this week, when the FDA ruled on the severity of the recall, a Synaptive spokesperson said. The company installed all necessary software patches last week.
Synaptive Medical sent an emergency letter to affected customers, which warned them of the device’s risks and directed customers to continually check the virtual tip offset value displayed on the user display interface to make sure it matched the obturator tip for the BrainPath ports.
If an incorrect tip offset value was displayed, customers were urged to adjust the offset for the BrainPath ports to the correct value, verify the value with the surgeon as being correct, check the accuracy of each tool on anatomical landmarks before navigation purposes, and to continue checking the accuracy of the tool periodically throughout the procedure. This procedure was meant to be a stopgap until Synaptive issued a patch to fix the software defect.
But on Nov. 16, Synaptive notified its operating room representatives to instruct all users not to switch between blue and gold ports until the software patch has been adequately applied.
Versions 1.5.0, 1.5.1 and 1.5.2 of the SYN-0026 model that were manufactured between Nov. 17, 2017 and April 24, 2018 and distributed between April 10, 2015 and July 27, 2018 have been recalled. A total of 36 devices have been recalled in the U.S.
This is not the first time a part of this system has been recalled.
In December 2015, the same model was recalled under Class II, “out of tolerance for radio frequency emissions,” according to a release by the FDA. Testing indicated that emissions from the BrightMatter Navigation system were higher than the standard when used with a defective cable.
In late October, the Canadian government said a software defect was initially discovered on Sept. 20 at Synaptive premises through routine internal testing. Health Canada, however, classified the issue as a lower-risk recall than the FDA. A spokesperson added that software defect affected no other regions.
(Editor’s note: This story has been updated to reflect additional information provided by a Synaptive spokesperson.)
Healthcare Analytics News™ is waiting for more information from the FDA.
Get the best insights in healthcare analytics directly to your inbox.
After FDA Approval, Pear Therapeutics Releases Drug Treatment mHealth App reSET
How Might the FDA's New Pilot Program Transform Digital Health?
Why the FDA is Making It Easier for Tech Heavyweights to Get Approvals