Class 2 Device Recall Obturator

• Date Initiated by Firm: January 25, 2019
• Create Date: April 17, 2019
• Recall Status: Terminated on December 11, 2020
• Recall Number: Z-1192-2019
• Recall Event ID: 82403
• 510(K)Number: K162330
• Product Classification: Colonoscope and accessories, flexible/rigid - Product Code FDF
• 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.
• Code Information: lots 19419-01, 19669-06, 19684-06
• FEI Number: 3009276788
• Recalling Firm/ Manufacturer: Medrobotics Corporation; 475 Paramount Dr; Raynham MA 02767-5178
• For Additional Information Contact: Mr. John Bonasera; 508-692-6460
• Manufacturer Reason for Recall: The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators.
• FDA Determined 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 no Obturators -and return the form it to Medrobotics by fax: +1-508-823-1703 or by email customerservice@medrobotics.com. 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 customerservice@medrobotics.com if you have any questions or need additional information.
• Quantity in Commerce: 24
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FDF