BOX KITDE0108 BYPASS KIT

  • Modèle / numéro de série
    Lot: 0214894171
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide and US Nationwide
  • Description du dispositif
    BOX KITDE0108 BYPASS KIT LUEBECK ( KITDE0108) || Product Usage: || The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm, 3.5 mm or 4.8 mm single use loading unit. The Endo GIA universal staplers will accommodate any of the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    COVIDIEN MEDTRONIC, 60 NIDDLETOWN AVE 2ND F, NORTH HAVEN CT 06473
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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.
  • Source
    USFDA