Events

Field Safety Notices about OLYMPUS TJF‐145 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 Olympus.

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
    Olympus xx is writing to inform you that we are issuing validated, new reprocessing instructions for the olympus tjf‐145 duodenoscope, consisting of revised manual cleaning and disinfection procedures to increase the safety margin against infection after ercp using the tjf‐145. these new reprocessing procedures should be implemented as soon as possible. the new cleaning procedure requires the use of a new cleaning brush (maj‐1534), which is enclosed with this letter. after the enclosed brushes are consumed, the brushes will be available for purchase in sufficient quantities to meet your facility’s needs through our normal sales order process. please note the maj‐1534 brush is a reusable brush, which can be sterilized by autoclave following use. instructions for sterilizing the maj‐1534 brush can be found in the enclosed, new reprocessing manual. .

Device

OLYMPUS TJF‐145 DUODENOSCOPE
  • Model / Serial
  • Manufacturer
    Olympus

Manufacturer

Olympus