Recall Z-1613-2023 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
Olympus Corporation of the Americas
Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100
| Date | May 19, 2023 (initiated Apr 18, 2023) |
| Status | Open, Classified |
| Reason | 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 | Device Design |
| Action | 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 |
| Quantity | 309278 pieces |
| Distribution | US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193182 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V Olympus Medical Systems Corp., Jan 17, 2020 |