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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The wire guide in the fusion omni-tome pre loaded sphincterotome being loaded incorrectly into the device resulting in the incorrect end of the wire guide exiting the sphincterotome. the preloaded wire guide has a black floppy distal tip which could be located at the proximal/user end and leaving the stiff end of the wire guide at the distal/patient end of the sphincterotome. difficulty advancing the wire guide may be experienced.