Events

Field Safety Notices about OLYMPUS ENDOEYE HD II Video Telescope

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 has initiated this removal action following a complaint of a damaged temperature sensor at the endoeye tip which caused the distal end to become abnormally hot. although no patient or user injury occurred as a result of this reported complaint, excessive heating of the endoeye distal end could result in patient or user injury. in an effort to prevent a potential risk to patient or user health, olympus is undertaking this action to remove the model and serial numbers identified above and to repair and return the devices. the repair to correct this problem will not be available until january 2016. however, we are requiring the return of your affected devices now so as to disable a feature on the video telescopes (“fog free”) which will prevent excessive heating of the endoeye distal end. once the repair parts are available in january 2016, we will contact you again for return of your devices for the permanent corrective action. .

Device

OLYMPUS ENDOEYE HD II Video Telescope
  • Model / Serial
    WA50040A, WA50042A
  • Manufacturer
    OLYMPUS

Manufacturer

OLYMPUS