Class 2 Device Recall EVIS EXERA II Colonovideoscope

• Date Initiated by Firm: December 21, 2022
• Date Posted: February 13, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1132-2023
• Recall Event ID: 91411
• 510(K)Number: K100584
• Product Classification: Endoscope, accessories, narrow band spectrum - Product Code NWB
• Product: EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve) Model/Serial: CF-Q180AL
• Code Information: UDI: 04953170202315 Serial number 2807443
• Recalling Firm/ Manufacturer: Olympus Corporation of the Americas; 3500 Corporate Pkwy; Center Valley PA 18034-8229
• For Additional Information Contact: SAME; 484-896-5000
• Manufacturer Reason for Recall: A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in error, potential for microbial contamination
• FDA Determined Cause: Process design
• Action: Olympus issued Urgent Field Safety Notice communication for the customers without the device on December 21, 2022 via FedEx 2-day delivery.. Letter states reason for recall, health risk and requires the following action: Although the device is no longer in your possession, Olympus requires you to take the following action: 1. Evaluate the situation according to your hospital procedures to determine if additional actions, including patient notification and/or clinical follow up, may be required. 2. Review affected patient records and report any potentially related adverse events (such as infection) to Olympus and FDA (instructions below). 3. Olympus requests that you acknowledge receipt of this letter by accessing the Olympus recall portal. Go to https://olympusamerica.com/recall. Enter reference number 0419 and provide your contact information as indicated in the portal. Olympus requests that you report any complaints, including infections, to Olympus and the FDA. Please report complaints to our Technical Assistance Center (TAC) at 1-800-848-9024, option 1. Contact (647) 999-3203 or at Cynthia.Ow@Olympus.com for any additional information or support concerning this matter. ***Update*** Firm provided recall delivered Urgent Medical Device Recall to one consignee dated 1/19/23 on 1/20/23 to customer. Letter states: Inspect your inventory for this model and serial number. Your local Sales Representative will assist in the return of the unit to Olympus and arrange either an exchange for a Certified Pre-Owned scope or a credit at fair market value. 2. Evaluate the situation according to your hospital procedures to determine if additional actions, including patient notification and/or clinical follow up, may be required. 3. Review affected patient records and report any potentially related adverse events (such as infection) to Olympus and FDA (instructions below). 4. Acknowledge receipt of this letter by e-mail response to your Sales Representative or to me directly a
• Quantity in Commerce: 1 unit
• Distribution: US Nationwide distribution in the states of CA, FL, GA, NY, OR, VA.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

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