“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.
The reusable staplers have applications in abdominal, gynecology, pediatric and thoracic surgery for resection, cross-sectional and anastomosis creation. They can be used for transverse cutting and resection of the pancreas. The recharge of a solouso has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and the creation of anastomosis. They can be used for transection and resection of the pancreas.