—#183562

Product

Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial numbers - Product Usage: designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as biopsy forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the airways and tracheobronchial tree.

FDA product code: EOQ — Bronchoscope (Flexible Or Rigid)
Device class: Class 2
Medical specialty: Ear, Nose, Throat
510(k) numbers: K061313
Affected lot / code info: All serial numbers

Why it was recalled

The BF-Q180 bronchoscope is being recalled because it does not have a 510(k) clearance, and the device is associated with a higher rate of patient infections than other comparable OMSC bronchoscopes.

Root cause (FDA determination)

Device Design

Action the firm took

Olympus Corporation notified direct customer accounts on 08/31/2020 via recall notification letter. Letter states reason for recall, health risk, and action to take. Actions to be taken by customers include the following: 1. Inspect your inventory and identify any BF-Q180 models. 2. Call your Olympus customer service representative at 1-888-524-7266 option 1 to make arrangements to return your BF-Q180 bronchoscope and discuss replacement options. Olympus will issue a Return Material Authorization for you to return any BF-Q180 at no charge. 3. The timing to return your BF-Q180 and receive a replacement product from Olympus will depend on existing inventory. An Olympus representative will inform you of the approximate timing for your return/replacement. 4. In recognition of the need to continue to serve patients, the BF-Q180 may be continued to be used clinically until suitable alternatives are sufficiently available. Olympus recommends continued adherence to the Instructions for Use related to reprocessing. Customers should note that the BF-Q180 has been validated for High Level Disinfection (HLD), Ethylene Oxide Sterilization and Sterrad NX. Clinical support staff is available to answer questions related to all reprocessing procedures. 5. Olympus will reimburse you $10,000 for each returned BF-Q180. 6. Access the Olympus recall portal to indicate that you have received this notification. Go to https ://olympusamerica.com/recall. Enter the recall number Recall-0366 and provide your contact information as indicated in the portal. 7. If you may have further distributed the BF-Q180, please identify your customers, notify them at once of this product recall, and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this recall notification letter.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy PO Box 610, Center Valley, Pennsylvania 18034-0610

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and International.

Timeline

Recall initiated: 2020-08-31
Terminated: 2024-02-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183562. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.