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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Investigation determined that end-users of the device were coiling the spring sheath outside of the endoscope and outside of the patient. when the spring sheath is either coiled or in a contorted configuration and the jaws are closed in rare occasions when excessive force is used on the handles the hypo tube would separate from the handle of the device and render the jaws inoperable.