Recall Z-1191-2019 ยท FDF Colonoscope And Accessories, Flexible/Rigid
Medrobotics Corporation
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
| Date | Jan 25, 2019 |
| Status | Terminated |
| Reason | The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators. |
| Root cause | Process control |
| Action | On January 25, 2019, the firm issued an Urgent Voluntary Medical Device Recall notification letter to its customers. The letter informed customers of the potential for the handle of the obturator to detach with the cone remaining in the patient's rectum. Patients were asked to take the following actions: 1. Immediately check your inventory and quarantine all Obturators that you have on hand to prevent their further use. Note: An Obturator may be located in the same sterilization tray as the Flex Rectoscope. 2. Please immediately complete the attached Acknowledgement form -- even if you have |
| Quantity | 35 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162330 | Flex Robotic System and Flex Colorectal Drive Medrobotics Corporation, May 4, 2017 |