—#197678

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

FDA product code: NWB — Endoscope, Accessories, Narrow Band Spectrum
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K100584
Affected lot / code info: UDI: 04953170202315 Serial number 2807443

Why it was recalled

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

Root cause (FDA determination)

Process design

Action the firm took

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

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: US Nationwide distribution in the states of CA, FL, GA, NY, OR, VA.

Timeline

Recall initiated: 2022-12-21
Posted by FDA: 2023-02-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197678. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.