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 were reports indicating that the irrigation pump was not functioning. therefore saline would not be provided to the tip. as a result the cooling function would be lost and could potentially cause the tip to heat up potentially resulting in tissue burns to the patient.