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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Bovie medical has become aware of an issue caused by incomplete insertion of the j-plasma handpiece cable plug into the generator receptacle. when the j-plasma handpiece with generator is used during surgical procedures without the cable plug being completely inserted into thgenerator the green indicator light to the left of the receptacle will illuminate event with an incomplete cable plug insertion. there have been no patient injuries reported as a result of this issue.