Device product
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.
Z-1191-2019
Product summary
- Event
- Event 82403
- Status
- Terminated
- Classification
- Class II
- Quantity
- 35
- Official record key
device-enforcement:Z-1191-2019
Official wording
Reason: The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators.
Code information: lots 18832-17, 19042-07, 19042-01, 19199-01, 18832-17, 19669-05, 19684-05
Distribution pattern: 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.
Derived failure modes
-
Unknown
The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators.