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 become aware that some customers may own legacy endoscopes where the screw connecting the suction arm to the control body could loosen with time. a loose suction arm may result in inadequate suctioning due to leakage of air. there is also the potential for organic debris to accumulate in the space between the suction nipple and control body. in some cases these events could cause cross-contamination between patients.