Company: Synaptive Medical Inc.
Date of Enforcement Report: 11/26/2018
Class II:
PRODUCT
BrightMatter Guide, Product Number SYN-0026, Versions: 1.5.0, 1.5.1 and 1.5.2 Product Usage: BrightMatter Guide can navigate a third-party port (NICO BrainPath device) by attaching Synaptive s custom Tracking Array to the port directly. As the BrainPath is navigable in two configurations (sheath only / sheath and obturator), the tip of the obturator is represented in the software with a tip extension beyond the bottom of the sheath. Note sheath and cannula are used interchangeably in this document.
Recall Number: Z-0470-2019
REASON
This recall has been initiated due to a software defect found in the Guide System software when used with NICO BrainPath ports under certain circumstances. When one trajectory is set with a blue port and another trajectory is set with a gold port, the software defect is triggered when the user switches between these trajectories during a surgical procedure.
RECALLING FIRM/MANUFACTURER
Synaptive Medical Inc. Toronto, CA on 10/9/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
37 units
DISTRIBUTION
Worldwide – US Nationwide Distribution and the country of Canada