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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Olympus has received customer complaints on the deterioration of the thunderbeat probe during surgical procedures. these complaints involve a combination of the following descriptions - the generation of audible and visual generator alarms the deformation of the components of the thunderbeat probe tip or jaw or the detaching of a fragment from the thunderbeat probe tip or jaw. olympus has investigated these complaints and the manufacturer has determined that improvements to the labeling for surgical technique including recommendations for best practices in cutting and dissection techniques during laparoscopic hysterectomy are appropriate to reduce/eliminate these complaints associated with device use.