BEUDAMED
    FDA Recall Terminated

    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: Z-0470-2019 · Initiated October 9, 2018

    Recall

    Recall Number
    Z-0470-2019
    Event Number
    81317
    Firm
    Synaptive Medical Inc
    FEI Number
    3012075008
    Product Code
    HAW
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 9, 2018
    Posted
    November 26, 2018
    Terminated
    August 12, 2021
    Address
    555 Richmond St West, Toronto Canada Suite 800

    Description

    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.

    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.

    Action

    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.

    Distribution

    Worldwide - US Nationwide Distribution and the country of Canada

    Quantity

    37 units