Events

Field Safety Notices about duodenoscope

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by PENTAX Europe GmbH.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Extra notes in the data
  • Reason
    Part of these activities are the revised reprocessing instructions issued to all users of the pentax medical ed-3490tk duodenoscope in june 2016 (ref. # fsca-pmj-16-01-1). in order to further reduce the risk of contamination, pentax wishes to inform users with this message about a potential problem associated with a distal cap of duodenoscopes of similar design. some of these are no longer being produced.

Device

duodenoscope

Manufacturer

PENTAX Europe GmbH
  • Manufacturer Parent Company (2017)
    HOYA Corp.
  • Source
    AMPMDRS