Recall – BrightMatter Guide 3D Imaging System Software Defect, Class I

Company: Synaptive Medical, Inc.
Date of Enforcement Report: 10/9/2018
Class l:

PRODUCT:

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.

Recall Number: Z-0470-2019

REASON:

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.

RECALLING FIRM/MANUFACTURER:

Synaptive Medical, Inc./Toronto, ON, Canada on 10/9/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
37 units in the U.S

DISTRIBUTION
U.S. Nationwide and Canada

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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Partners located in the US (CA, FL, MA, MN) and Italy.