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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Tears: through standard product quality testing it was noted that the adhesive labels intended to keep the drape folded were found in some instance unintentionally overlapping multiple folds of the drape. cloudy/waxy appearance: through customer feedback intuitive surgical found that some of the drapes used with the da vinci systems may exhibit a cloudy/waxy appearance.