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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Manufacturer is issuing validated new reprocessing instructions for the olympus tjf-160f /vf duodenoscopes ("tjf-160f /vf") consisting of revised manual cleaning and high level disinfection procedures. these new reprocessing procedures should be implemented as soon as possible. the new cleaning procedure requires the use of a new cleaning brush (maj-1534). in addition to the new cleaning brush referenced above the new tjf-160f /vf reprocessing procedures require additional flushing and forceps elevator raising/lowering steps during precleaning and manual cleaning manual disinfection endoscope rinsing and alcohol flushing.