Olympus Corporation of the Americas Recall 87296
Description: 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.
Olympus Corporation of the Americas Recall 87296 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1292-2021 |
| Event ID | 87296 |
| Event Description | 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. |
| Product Type | 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. |
| Quantity | 1564 devices total (Domestic: 627 devices, Foreign: 937 devices) |
| Recall 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). |
| Device Classification | 20210331 |
| Device Code Info | Model: TJF-Q190V |
| Center Classification Date | 20210322 |
| Recall Initiation Date | 20210128 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | Letter |
| Similar To |