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 winter ibe (owi) has initiated this removal action after receiving an increased number of complaints regarding loop wires breaking at the distal end of the referenced electrodes. investigations have confirmed that loop wires can break during the intended use of the electrodes. as a result a fragment may fall inside the patient and will need to be retrieved. under certain circumstances the retrieval of this fragment could require additional surgical treatment.