BEUDAMED
    FDA Recall Terminated

    Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to organs, tissues and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced orally when indications consistent with the requirement for procedure are observed in adult and pediatric

    Recall: Z-2077-2016 · Initiated April 6, 2016

    Recall

    Recall Number
    Z-2077-2016
    Event Number
    73894
    Firm
    Pentax Medical Company
    FEI Number
    1000080301
    Product Code
    ITX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 6, 2016
    Posted
    June 28, 2016
    Terminated
    December 21, 2017
    Address
    3 Paragon Dr, Montvale, NJ, 07645-1782

    Description

    Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to organs, tissues and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced orally when indications consistent with the requirement for procedure are observed in adult and pediatric

    Reason

    Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.

    Action

    Pentax sent an Urgent Field Correction letter dated April 6, 2016 to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were reminded to carefully check that all accessories are intact, that no parts have fallen off and become lodged within the endoscope's instrument/suction channel and to ensure that any therapeutic devices passed through the instrument channel are accounted for after use. If the instrument/suction channel does become blocked or clogged due to the accumulation of debris, an accessory that cannot be removed, or other cause, do NOT attempt to correct the blockage or continue to use the endoscope. Customers were instructed to contact their local PENTAX Medical Service facility to have the endoscope repaired. Customers with questions were instructed to call 800-431-5880, ext 2064.

    Distribution

    Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam

    Quantity

    819 units