—#199714

Product

Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100

FDA product code: FDT — Duodenoscope And Accessories, Flexible/Rigid
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K193182
Affected lot / code info: UDI-DI: 04953170403019; Item code: Catalog N5786100 Lots Lower than H2530

Why it was recalled

The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the endoscope during use. Consequences of a detached cover could include the risk of aspiration, inhalation, or obstruction that will require urgent removal, and/or burns from an uncovered distal end.

Root cause (FDA determination)

Device Design

Action the firm took

An URGENT - Medical Device Recall notification letter dated 4/18/23 was sent to customers. Instructions for Use: Correct application and inspection of the distal cover before the procedure is critical. In addition, inspection of the distal end after the procedure is also important. Olympus representatives are available to provide additional support and training. Please contact your local Olympus facility to further discuss. Action Required: Our records indicate that you have purchased or may use the MAJ-2315 Distal Covers with the original design. Olympus requires you to take the following action: 1. Immediately locate and no longer use the MAJ-2315 with the original design. The original design can be identified by the item code (below) or by lot numbers less than H2530. The image below depicts the area where the lot number is identified. The lot number is on the Carton box and Pack. Model: MAJ-2315 Item code: N5786100 Lot number: Lower than H2530 2. Contact our Olympus Customer Service Team at 1-800-848-9024, option 2. Olympus will issue a Return Material Authorization to return any affected product at no charge to you. Olympus will issue a credit to your facility upon return of affected product. 3. Olympus requests that you acknowledge receipt of this letter through the Olympus recall portal. a) Go to https://olympusamerica.com/recall b) Enter the recall number: 0423 c) Complete the form as instructed. 4. If you have distributed these devices outside your facility, please notify your customers of this matter immediately. Your notification to your customers may be enhanced by including a copy of this letter. Olympus requests that you report complaints, including mucosal injuries, distal cover detachment and adverse events, to Olympus. Please report complaints to our Technical Assistance Center (TAC) at 1-800-848-9024, option 1, to report complaints. Adverse events experienced with the use of this product may also be reported to the Food and Drug Administration

Recalling firm

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

Distribution

Distribution pattern: US Nationwide.

Timeline

Recall initiated: 2023-04-18
Posted by FDA: 2023-05-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #199714. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.