Signia Power Handle

Fabricant

  • 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
    HPRA

9 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Model: , Affected: Item code SIGPHANDLE
  • Manufacturer
  • Modèle / numéro de série
    SIGPHANDLE-UDI 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  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution: US (Nationwide).
  • Description du dispositif
    Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) || The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Staple" Technology, has applications in open and minimally invasive general abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis.
  • Manufacturer
  • Modèle / numéro de série
    All handles manufactured between January 2017 and October 2017 Serial Numbers: Multiple
  • Description du dispositif
    Motorized cutting stapler handpiece
  • Manufacturer
  • Modèle / numéro de série
  • Description du dispositif
    Surgical equipment/ Anaesthesia - surgical equipment
  • Manufacturer
  • Modèle / numéro de série
  • Description du dispositif
    Covidien Signia Power Handles, Covidien llc
  • Manufacturer
4 en plus