Covidien Endo GIA Articulating Reloads with Tri-Staple Technology
모델명 / 제조번호(시리얼번호)
Covidien Endo GIA Articulating Reloads with Tri-Staple TechnologyEndo GIA 45mm Articulating Medium/Thick Reload with Tri-Staple Technology Item Code: EGIA45AMT Lot: N7L0521KXARTG:181429 Endo GIA 45mm Extra Thick Black Articulating Reload with Tri-Staple TechnologyItem Code: EGIA45AXT Lots: N8A0907KX and N8A0146KX ARTG:181429Endo GIA 60mm Articulating Vascular/Medium Loading Unit with Tri-Staple TechnologyItem Code: EGIA60AVM Lot: N8B0088KX ARTG:186247
“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.