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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There was an investigation of customer complaints regarding the breakage of the endoscope's insertion tube bending section during surgical procedures. to date some of these complaints are associated with tissue trauma including one complaint of perforation and two complaints of insertion tubes which were stuck inside the patient and had to be surgically removed. olympus is providing a two-page instructions for safe use to remind customers of inspection instructions in the existing operation manual and also provide pictures and instructions to assist in performing the inspection.