BEUDAMED
    FDA Enforcement Class II Terminated

    Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract.

    Recall: Z-0006-2013 · Reported October 10, 2012

    Enforcement

    Recall Number
    Z-0006-2013
    Event ID
    63196
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    US Endoscopy Group Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 10, 2012
    Initiation Date
    November 14, 2011
    Classification Date
    October 3, 2012
    Termination Date
    July 2, 2013
    Address
    5976 Heisley Rd, N/A, Mentor, OH, 44060-1873, United States

    Description

    Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract.

    Reason

    When the outer catheter is either coiled or in a contorted configuration outside of the endoscope and the patient, and excessive force is applied to the handle, the jaws may become inoperable and may become stuck in the open condition.

    Code Info

    Model #00711177; S/N: 52979, 52981, 52982, 53643, 53644, 53891, 53892, 54238

    Distribution

    Worldwide Distribution -- USA (nationwide) including the states of AL, AR, AZ, CA, FL, GA, HI, IA, IL, KY, LA, MD, ME, MI, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, and WI; and to the following countries: Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Caribbean, Chile, Columbia, Croatia, Czech Republic, Denmark, Ecuador, El Salvador, Estonia, Finland, France, Germany, Great Britain, Greece, India, Ireland, Israel, Italy, Jordan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, and United Arab Emirates.

    Quantity

    1153