BEUDAMED
    FDA Recall Terminated

    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: Z-1292-2021 · Initiated January 28, 2021

    Recall

    Recall Number
    Z-1292-2021
    Event Number
    87296
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    FDT
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    January 28, 2021
    Terminated
    March 13, 2024
    Address
    3500 Corporate Pkwy PO Box 610, Center Valley, PA, 18034-0610

    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.

    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).

    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.

    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)