BEUDAMED
    FDA Enforcement Class II Terminated

    Obturator (long cone), Part number 25162 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Flex Robotic System. The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during visualization of and surgical site access to the anus, rectum and distal colon. The Flex Robotic System is intended for use in adults (e22 years of age). The Flex Colorectal Drive is intended for robot-assisted visualization of and surgical site access to the anus, rectum, and distal colon in adults (e22 years of age). The Flex Colorectal Drive also provides accessory channels for compatible flexible instruments used in surgery.

    Recall: Z-1191-2019 · Reported April 24, 2019

    Enforcement

    Recall Number
    Z-1191-2019
    Event ID
    82403
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medrobotics Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2019
    Initiation Date
    January 25, 2019
    Classification Date
    April 17, 2019
    Termination Date
    December 11, 2020
    Address
    475 Paramount Dr, N/A, Raynham, MA, 02767-5178, United States

    Description

    Obturator (long cone), Part number 25162 Product Usage: The obturator is a component of the Flex Rectoscope which is an accessory to the Flex Robotic System. The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during visualization of and surgical site access to the anus, rectum and distal colon. The Flex Robotic System is intended for use in adults (e22 years of age). The Flex Colorectal Drive is intended for robot-assisted visualization of and surgical site access to the anus, rectum, and distal colon in adults (e22 years of age). The Flex Colorectal Drive also provides accessory channels for compatible flexible instruments used in surgery.

    Reason

    The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators.

    Code Info

    lots 18832-17, 19042-07, 19042-01, 19199-01, 18832-17, 19669-05, 19684-05

    Distribution

    Worldwide Distribution - US Nationwide in the states of CO, DC, FL, IL, MD, MO, NY, OK, PA, TX, and VA. Foreign distribution to Australia and Italy.

    Quantity

    35