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 upper/lower g.I. endoscopes are provided with an air/water valve. as an alternative the optionally available of-b194 gas/water feeding valve may be used in place of the standard air/water valve to deliver a non-explosive gas (c02) for insufflation. we have been informed about a product issue involving the of-b194 gas/water feeding valve. the reported defect may cause improper stoppage of the supply of co2 gas during an endoscopic procedure with the potential for serious hazard to the patient (i.E. increased risk of perforation due to continuing flow of co2 gas). pentax medical has discovered a manufacturing assembly failure which cannot be corrected at the user facility and therefore the of-b194 gas/water feeding valve must be removed from use immediately.