Ligasure blunt tip laparoscopic sealer/divider

Fabricant

  • Adresse du fabricant
    Covidien (UK) Commercial Ltd 154 Fareham Road Gosport Hampshire PO13 0AS Tel: 01329 224000 Fax: 01329 224418Email: PRMS.ComplaintsDepartment@covidien.com
  • 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
    MHRA

3 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Model Catalog: LF1537 (Lot serial: 193333); Model Catalog: LF1537 (Lot serial: 193331); Model Catalog: LF1537 (Lot serial: 193207); Model Catalog: LF1537 (Lot serial: 190307); Model Catalog: LF1537 (Lot serial: 192093); Model Catalog: LF1537 (Lot serial: 191661); Model Catalog: LF1537 (Lot serial: 191224); Model Catalog: LF1537 (Lot serial: 192664)
  • Description du dispositif
    LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER
  • Manufacturer
  • Modèle / numéro de série
    Model Catalog: LF1637 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: LF4318 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Description du dispositif
    LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER;LIGASURE IMPACT OPEN SEALER/DIVIDER
  • Manufacturer
  • Modèle / numéro de série
    Lot No.: 188856, 190048, 190107, and 190307 through 193333 (88 lots).
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA and countries including: Australia, Canada, France, Germany, Japan, Puerto Rico, Singapore, and Uruguay.
  • Description du dispositif
    Covidien, LigaSure, Blunt Tip Laparoscopic Sealer/Divider, 5 mm-37 cm, REF LF1537, Sterile EO, Covidien, Valleylab, a division of Tyco Healthcare Group LP, 5920 Longbow Drive, Boulder, CO 80301 || Intended use: LigaSure 5 mm devices are electrosurgical instruments designed to permanently seal and divide vessels, tissue bundles, and lymphatics.
  • Manufacturer