BEUDAMED
    FDA Enforcement Class II Terminated

    Choledochoscope Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Common Bile, Hepatic, Cystic and Pancreatic Ducts. The instrument is introduced via the working channel of a Duodenoscope positioned for access to the Common bile Duct when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

    Recall: Z-2067-2016 · Reported July 6, 2016

    Enforcement

    Recall Number
    Z-2067-2016
    Event ID
    73894
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pentax Medical Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 6, 2016
    Initiation Date
    April 6, 2016
    Classification Date
    June 28, 2016
    Termination Date
    December 21, 2017
    Address
    3 Paragon Dr, Montvale, NJ, 07645-1782, United States

    Description

    Choledochoscope Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Common Bile, Hepatic, Cystic and Pancreatic Ducts. The instrument is introduced via the working channel of a Duodenoscope positioned for access to the Common bile Duct when indications consistent with the need for procedure are observed in adult and pediatric patient populations.

    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.

    Code Info

    Model #'s FCP-8P and FCP-9P

    Distribution

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

    Quantity

    50 units