Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
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Olympus has initiated this recall 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 manufacturer is not aware of any patient or user injury excessive heating of the endoeye distal end could result in patient or user injury. to prevent a potential risk to patient or user health olympus is undertaking this action to repair the devices by disabling a specific feature on the video telescopes ("fog-free function") to prevent excessive heating of the endoeye distal end under certain conditions.