Events

Safety Alert for Valleylab Cool-Tip RF electrode and auxiliaries - MS Registry: 10349000258. Affected lots - see annex. http://en.wikipedia.org/w/eng/wiki/index.php

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by AUTO SUTURE DO BRASIL LTDA.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1161
  • Date
    2012-08-10
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    Anvisa is following this action.
  • Reason
    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
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “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