FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1292-2021
- Recalling firm
- Olympus Corporation of the Americas
- Product
- 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.
- Status
- Terminated
- Initiated
- 2021-01-28
- Posted
- not on file
- Terminated
- 2024-03-13
- 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 occurrence of similar incidents.
- 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.
- Lot, serial or model codes
- Model: TJF-Q190V
- 510(k) numbers
- ["K193182"]
- PMA numbers
- not on file
- Product code
- FDT
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28