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 is conducting a corrective action of all tjf-q180v duodenoscopes in order to replace the forceps elevator mechanism. olympus has also updated the existing tjf-q180v operation manual and reprocessing manual with a new operation manual and a new reprocessing manual.