“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.
This equipment is an argon gas administration system that is used in conjunction with an electrosurgical generator for the effects of argon gas assisted electrosurgery. The system offers precise energy application for non-contact coagulation on large surface areas. The coagulation intensified by argon, hemostatic hemostasis with a thinner and more flexible eschar, less possible bleeding and less tissue damage.