FDA recall Z-1192-2019

Medrobotics Corporation · Class II · device

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 for recall

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

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.

Key facts

Status
Terminated
Initiation date
2019-01-25
Report date
2019-04-24
Termination date
2020-12-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Raynham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1192-2019