Events

Safety Alert for Endeavor Light System

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

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
    2013-12-30
  • Event Date Posted
    2013-12-30
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131230.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: orascoptic endeavor light system medical device manufacturer, orascoptic, has issued a medical device safety alert concerning its endeavour light system [part no.: 910114-x; serial no.: 78100100 to 78113815]. the manufacturer is informing end users of a possible light output issue with the endeavour light system, which was shipped to place of distribution from november 2011 through august 2013. the manufacturer discovered that intermittent to no light output may occur without proper placement of the spiral temple clip that was provided with the initial purchase. this clip is a critical component of the endeavour light system that should be used to secure the cable to the temple arm of the frame. as a preventive measure, a complimentary spiral temple clip is offered to end users along with instructions on how to place the clip as a means to secure the cable to the temple arm of his/her loupes and prevent strain on the cable that allows power to reach the headlight led. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 30 december 2013.

Device

Endeavor Light System
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Orascoptic Endeavor Light System
  • Manufacturer
    Orascoptic

Manufacturer

Orascoptic