FDA Recall Terminated

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.

Recall: Z-1192-2019 · Initiated January 25, 2019

Recall

Recall Number: Z-1192-2019
Event Number: 82403
Firm: Medrobotics Corporation
FEI Number: 3009276788
Product Code: FDF
Status: Terminated
Root Cause: Process control
Initiated: January 25, 2019
Terminated: December 11, 2020
Address: 475 Paramount Dr, Raynham, MA, 02767-5178

Description

Reason

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

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 no Obturators -and return the form it to Medrobotics by fax: +1-508-823-1703 or by email [email protected]. 3. Ensure relevant staff members -- including clinicians, OR staff, engineers, and product returns staff -- are informed of this recall. 4. If you have supplied any Obturators to any other organization, please advise that organization of this recall and notify Med robotics of that organization's name, address, and contact person so that we may contact them immediately. Please contact Med robotics Customer Service at 1 +508-692-6104 or at [email protected] if you have any questions or need additional information.

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