EVIS EXERA III Bronchovideoscope (Aizu Olympus) – Incorrect Usage (2022)

Check Your Product

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

Reason for Recall

As stated by FDA

The recalled unit was utilized in a veterinary endoscopy procedure in advance of being assigned to healthcare facilities as a loaner.

Recommended Action

Per FDA guidance

An Urgent Field Safety Notice was distributed by the recalling firm on 07/20/2022 notifying consignees that a bronchoscope utilized in a veterinary endoscopy procedure was subsequently distributed as a service loaner in error. The device was utilized in a single procedure on a cat. Actions to be taken by customers include evaluating the situation according to hospital procedure to determine if patient notification or follow up may be required, review patient records and report any potentially adverse events to Olympus and FDA and acknowledge receipt of the recall notification by email or through the Olympus recall portal at https://olympusamerica.com/recall. Customers with any questions may contact Cynthia Ow by phone at (647)999-3203 or by email at Cynthia.Ow@Olympus.com. Customers reporting complaints associated with this recall event are to call Olympus at 1-800-848-9024, option 1.