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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In march 2017 as part of field action 2017-001-c pentax medical informed customers about a potential cracks and gaps in the distal cap of the ed-3490tk and instituted a distal cap inspection program. during discussion with the us fda as part of this field action pentax medical agreed to redesign the ed-3490tk's forceps elevator mechanism o-ring and distal end to reduce the risk of cross-contamination resulting from body fluids entering portions of the ed-3490tk that cannot be easily cleaned.