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.
This recall has been terminated (originally issued November 26, 2018).
- Company
- Synaptive Medical Inc
- Recall Initiated
- October 9, 2018
- Posted
- November 26, 2018
- Terminated
- August 12, 2021
- Recall Number
- Z-0470-2019
- Quantity
- 37 units
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide - US Nationwide Distribution and the country of Canada
Lot / Code Info
Serial Numbers: 0063HJ5Y062 00635F48562 00635GTYK32 00638HTZK32 0063G6DRM12 0063CPBRM12 006395Q2Z52 0063J9BD062 00634X19562 0063GN0B562 00637BP9562 0063JTDW462 00638J89562 006360JV462 0063F1Q2Z52 0063FGWYK32 006384WYK32 00635YH8562 0063C2SKH72 00635NWPK12 0063DKWYK32 006358Q2Z52 0063HM0B562 0063DZPGP12 00634BBD062 00636L48562 0063DD8GP12 0063HCZ1Z52 006318XYK32 0003CZDRLC2 0063GLD6562 0063HRZYK32 006317B8562 006348M5562 0063HGTYK32 0063FHXY062 00634DBD062
Root Cause
Software design
Action Taken
Synaptive Medical sent an Urgent Medical Device Recall letter dated October 9, 2018 via registered priority mail. The letter identified the affected product, problem and actions to be taken until a software patch is released. Customers were requested to complete and return the enclosed Acknowledgement and Receipt form to Synaptive Medical Inc. For questions call 1-844-462-7246.