The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Synaptive Medical, Inc. BrightMatter Guide with SurfaceTrace Registration
- Model/Product Numbers: SYN-0026 (Versions: 1.5.0, 1.5.1 and 1.5.2)
- Manufacturing Dates: November 17, 2017 to April 24, 2018
- Distribution Dates: April 10, 2015 to July 27, 2018
- Devices Recalled in the U.S.: 36
Synaptive Medical’s BrightMatter Guide with SurfaceTrace Registration provides detailed three-dimensional (3D) images of a patient’s brain to help surgeons safely navigate surgical tools used during brain surgery.
Reason for Recall
Synaptive Medical has initiated this recall due to a software defect found in the BrightMatter Guide System’s software that could potentially result in serious or life-threatening patient harm.
When the BrightMatter Guide System is used with two configurations of a specific third-party port (the NICO BrainPath device), a software defect may be triggered upon switching between the configurations which affects the system’s display and prevents the surgeon from being able to accurately see the location of surgical tools in the patient’s brain. In the event this software defect occurs, the surgeon could potentially damage the patient’s brain and vascular structures.
Who May be Affected
- Surgeons and other trained medical personnel using Synaptive’s BrightMatter Guide with SurfaceTrace Registration to perform neurosurgical procedures.
- Patients undergoing a neurosurgical procedure using Synaptive’s BrightMatter Guide with SurfaceTrace Registration.
What to Do
On October 9, 2018, Synaptive Medical sent affected customers a recall letter informing them of the device’s risks. In the letter, Synaptive directed customers to:
- 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:
- 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; and
- 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.
Additionally, on November 16, 2018, Synaptive Medical 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.
Customers who have questions or need additional information or support regarding this recall should contact their onsite Synaptive Medical Clinical Support Staff.
Date Recall Initiated
October 9, 2018
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Health care professionals employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.