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.
FDA Recall Z-1292-2021 · Posted None
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Recalling FirmOlympus Corporation of the Americas
Recall StatusTerminated
Product CodeFDT
Date Initiated2021-01-28
Date Terminated2024-03-13
Product Quantity1564 devices total (Domestic: 627 devices, Foreign: 937 devices)
Reason for Recall
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).
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.
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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