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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A revised instructions for use (ifu) for reprocessing of da vinci endowrist instruments will be released. these changes have been implemented to ensure customers have clear information related to the use and reprocessing of da vinci instruments and accessories and to assist da vinci customers with compliance to local requirements. the current ifu is still valid. this update improves the process improves the clarity of the instructions themselves and allows for alkaline cleaners and is not being performed for safety issues or the ifu is defective.