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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The recall is being conducted due to the potential for the handle pins to disengage which could compromise handle unlatching. this may complicate removal of the device jaws from targeted tissue. in an open procedure there is a risk that the disengaged handle pin may fall into the patient cavity and go unnoticed.
Model Catalog: LS1520 (Lot serial: LOTS S1CB010X THROUGH S1HB013P); Model Catalog: LS1500 (Lot serial: LOTS S1CB010X THROUGH S1HB013P); Model Catalog: LS1500 (Lot serial: MODELL # LS1500 :); Model Catalog: LS1520 (Lot serial: MODELL # LS1500 :); Model Catalog: LS1500 (Lot serial: LOTS S1CB001 THROUGH S1JB048X); Model Catalog: LS1520 (Lot serial: LOTS S1CB001 THROUGH S1JB048X); Model Catalog: LS1500 (Lot serial: MODELL # LS1520 :); Model Catalog: LS1520 (Lot serial: MODELL # LS1520 :)
“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.