BEUDAMED
    FDA Recall Terminated

    Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

    Recall: Z-0757-2016 · Initiated January 8, 2016

    Recall

    Recall Number
    Z-0757-2016
    Event Number
    73059
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    FDT
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    January 8, 2016
    Posted
    February 4, 2016
    Terminated
    January 9, 2017
    Address
    3500 Corporate Pkwy PO Box 610, Center Valley, PA, 18034-0610

    Description

    Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

    Reason

    Olympus America Inc is conducting a voluntary removal/corrective action of all TJF-Q180V duodenoscopes in order to replace the forceps elevator mechanism Olympus is replacing the forceps elevator mechanism with a new forceps elevator design consistent with the design specification in the recently cleared TJF-Q180V 510k.

    Action

    Olympus America Inc. sent an Urgent Notification letter dated January 15, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory for the affected product, Olympus will contact facilities to make arrangements for return of the TJF-Q180V duodenoscope(s) for the elevator mechanism replacement. For questions call (484) 896-5688.

    Distribution

    US Nationwide Distribution except PR

    Quantity

    4436