Recall Z-1192-2019— Medrobotics Corporation

Name: FDA recall Z-1192-2019
Creator: U.S. Food and Drug Administration
Published: 2019-01-25

Class II · Terminated

Class II FDA medical device recall by Medrobotics Corporation, initiated 2019-01-25, terminated 2020-12-11. It names one FDA 510(k) clearance: K162330. Product: Obturator (shortcone), Part number 26114 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..

Recalling firm: Medrobotics Corporation
Classification: Class II
Status: Terminated
Initiated: 2019-01-25
Terminated: 2020-12-11
Firm location: Raynham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K162330 — Flex Robotic System and Flex Colorectal DriveMedrobotics Corporation·cleared 2017-05-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Obturator (shortcone), Part number 26114 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 for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.