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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Pentax medical has been notified of a potential risk related to the use of certain models of ultrasound gastroscope listed above in combination with aspiration needles if the instructions for use document is not followed carefully by the user. specifically if the user fails to properly position the elevator while advancing the aspiration needles through the endoscope then the needle can derail from the elevator. this could result in the needles not being visible in the endoscopic or sonographic field of view leaving to the possibility of patient injury such as perforation.