Recall Z-1292-2021 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
Olympus Corporation of the Americas
Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
| Date | Jan 28, 2021 |
| Status | Terminated |
| Reason | Olympus Medical Systems Corporation (OMSC) has received complaints of mucosal injury associated with the forceps elevator region of the TJF-Q190V duodenoscope, including the distal cover (model MAJ- 2315). |
| Root cause | Under Investigation by firm |
| Action | On 2/5/2021, Olympus issued Urgent Device Correction notices to customers via letter informing them Olympus has identified an increase in the number of complaints from customers reporting that mucosal tissue was found within the single-use distal cover, MAJ-2315, after withdrawing the TJF-Q190V duodenoscope from the patient. In the reported complaints, the user facilities have reported mucosal injuries in the esophagus, stomach, and duodenum. Olympus is thoroughly investigating the root cause or causes of these reported events. This notice included information that may reduce the potential oc |
| Quantity | 1564 devices total (Domestic: 627 devices, Foreign: 937 devices) |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NH, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Japan, Europe, Australia. |
| 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 |