Events

Alerte De Sécurité sur Valleylab Cool-Tip RF electrode and auxiliaries - MS Registry: 10349000258. Affected lots - see annex. http://en.wikipedia.org/w/eng/wiki/index.php

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par AUTO SUTURE DO BRASIL LTDA.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1161
  • Date
    2012-08-10
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    Anvisa is following this action.
  • Cause
    Potential degradation hazard of localized foil over dgp-hp rfa high-power single-use grounding plates. this degradation of the metal foil may result in an electrical disconnection and an undesirable thermal profile during use, which may result in burns to the patient at the site of the plaque.
  • Action
    (1). Immediately quarantine the device and discontinue use. (2). Immediately inform all users of the DGPHP RFA High Power single use grounding plates and the Cool-tip RF Electrode Kit on this Recall. (3). Fill in and Sign the Customer Return Form below, REGARDLESS OF HAVING OR NOT the affected product at your location and send by e-mail to atendimento.brasil@covidien.com or by Fax: 0800- 17-80-17. (4). If you do not have affected lots units in your inventory, simply send the Customer Return Form indicating that you have zero (0) units. (5). If you have affected lots units, please return the affected product as follows: (a). Customers who purchased the product directly from Auto Suture do Brasil Ltda. Please fill in the form and send by e-mail: atendimento.brasil@covidien.com or Fax: 0800- 17-80-17. Upon receipt of your form, Auto Suture Customer Service will coordinate the collection and will bear the costs related to the freight. (B). If you purchased the product from a distributor, please complete the form and contact your Distributor directly. The completed form and all affected units must be returned through the Distributor. See attached Letter to the Client. http://en.wikipedia.org/w/index.php?title

Device

Valleylab Cool-Tip RF electrode and auxiliaries - MS Registry: 10349000258. Affected lots - see a...

Manufacturer

AUTO SUTURE DO BRASIL LTDA
  • Société-mère du fabricant (2017)
    Medtronic plc
  • 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
    ANVSANVISA