—#205324

Product

Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator

FDA product code: FDT — Duodenoscope And Accessories, Flexible/Rigid
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K220587
Affected lot / code info: UDI: 04953170441271 All lot numbers

Why it was recalled

Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result include the risk of mucosal injury, tissue damage, bleeding, perforation, or obstruction due to retained distal cover in the gastrointestinal tract that would require urgent medical intervention for removal, and/or burns from the use an uncovered duodenoscope distal end. Detachment of a distal cover in the oral cavity may result in aspiration, airway obstruction, or respiratory distress and would require immediate medical intervention for removal.

Root cause (FDA determination)

Device Design

Action the firm took

Olympus issued Urgent: Medical Device Corrective Action letter on December 8, 2023. Letter states reason for recall, health risk and action to take: Our records indicate that you have purchased the MAJ-2315 Distal Covers. Olympus requires you to take the following action: 1. Please ensure that all Olympus TJF-Q190V duodenoscope users at your facility are knowledgeable on MAJ-2315 distal cover attachment and attachment verification to ensure the safe use of these devices. 2. Please ensure that the reference guide (Appendix) is distributed to all parties at your facility who will be involved in the process of attaching the MAJ-2315 distal cover. 3. Olympus requests that you acknowledge receipt of this letter and provide a contact for in-servicing. Complete the enclosed response form and return it to our recall partner, Sedgwick, via e-mail at olympus2891@sedgwick.com or by fax at 866-534-0018. For any questions about the acknowledgement form, please call the Sedgwick team at 888-216-7307. 4. An Olympus representatives will be contacting you to schedule an upcoming on-site, in-service training at your user facility on MAJ-2315 distal cover attachment and attachment verification to ensure the safe use of these devices. 5. If you have distributed these devices outside your facility, please provide a copy of this letter to those facilities immediately. Olympus requests that you report complaints, including mucosal injuries, distal cover detachment and/or cracks, and adverse events, to our Technical Assistance Center (TAC) at 1-800-848-9024, option 1. Adverse events experienced with the use of this product may also be reported to the Food and Drug Administration MedWatch Adverse Event Reporting program either online, by regular mail or by fax. If you require additional information, please do not hesitate to contact me directly at (647) 999-3203 or at Cynthia.Ow@Olympus.com.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2023-12-08
Posted by FDA: 2024-02-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #205324. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.