Events

Safety Alert for ENDOEYE HD II Video Telescope

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Olympus.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2017-02-06
  • Event Date Posted
    2017-02-06
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170206a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: olympus endoeye hd ii video telescope medical device manufacturer, olympus, has issued a medical device safety alert concerning its endoeye hd ii video telescope [product code: w wa50040a and wa50042a; serial number: all]. the manufacturer has initiated this fsca after discovering that the endoeye distal end can become abnormally hot if the temperature sensor at the device’s tip is damaged. although no customer complaints have been received referring to this issue and thus no patient or user injury has occurred, 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, the manufacturer is undertaking the action to remove the model and serial numbers identified above and to modify and return the devices. according to the manufacturer, disabling a specific feature on the video telescope (i.E. fog-free function) will prevent excessive heating of the endoeye distal end in case of certain faults. the manufacturer will provide an addendum to the instructions for use with the modified devices. affected users are advised to take the following actions:- inspect the inventory for the captioned devices and discontinue use of any affected devices. return the affected devices for modification. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 06 february 2017.

Device

ENDOEYE HD II Video Telescope
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Olympus ENDOEYE HD II Video Telescope
  • Manufacturer
    Olympus

Manufacturer

Olympus