Olympus Corporation of the Americas 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 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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