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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Pentax medical has been working with the u.S. food and drug administration ("fda") as part of an industry-wide initiative to determine what additional steps if any could be undertaken to reduce the risk of infection in flexible endoscopes used for ercp procedures. the updated reprocessing ifus were developed after rigorous validation testing and ongoing discussions with fda to further enhance the safety margin and show with a high degree of assurance that the updated reprocessing ifus when followed correctly effectively clean and disinfect the duodenoscope.