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 manufacturer olympus medical systems corp (omsc) has initiated this corrective action following complaints on the urf-p6/p6r insertion tube and breaks of the bending tube. these complaints have not resulted in any known adverse event. the urf-p6/p6r endoscopes are intended for use in endoscopic diagnosis and treatment within the ureter kidney and biliary tract (common bile duct and hepatic duct). omsc is aware of adverse events on the urf-v2/v2r endoscopes which have a similar structure to the urf-p6/p6r endoscopes. olympus is providing a two-page instructions for safe use to remind customers of inspection instructions in the existing operation manual and also provide pictures and instructions to assist in performing the inspection.