Versaport Bladeless Optical 5mm Trocar with Fixation Cannula (Abdominal and thoracic trocar)
Modelo / Serial
Versaport Bladeless Optical 5mm Trocar with Fixation Cannula (Abdominal and thoracic trocar)Multiple product codes and lot numbers:ONB5LGF (Lots N2K0019X through N3A0294X)ONB5SHF (Lots N2J0265X through N3A0391X)ONB5STF (Lots N2H0353X through N3D0033X)ONB5STF2C (Lots N2J0211X through N3D0118X)ONBFCA5SH (Lots N2J0315X through N3A0389X)ONBFCA5ST (Lots N2J0150X through N3C0683X)ARTG Number: 178557
“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.