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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Some suction valves of the affected lot numbers may contain a component with dimensional discrepancy which may cause sticking during an endoscopy procedure. this recall was initiated because through internal review medivators has identified an increasing trend in occurrence rate of a situation where defendo suction valves were sticking during and endoscopy procedure. the complaints regarding potential sticking of defendo suction valves do not pose any additional risk of injury to device users or patients. in worst case conditions sticking of valves could result in a delay of the ongoing endoscopy procedure.