Recall Z-1071-2024 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
Olympus Corporation of the Americas
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
| Date | Feb 9, 2024 (initiated Dec 8, 2023) |
| Status | Open, Classified |
| Reason | 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 | Device Design |
| Action | 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 |
| Quantity | 24300 units (box of 20 pieces) |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220587 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V Olympus Medical Systems Corp., May 11, 2022 |