Events

Safety Alert for Stapler Roticulator Disposable Auto Suture - Record: 10349000055 - Lots Affected - SEE NO ANNEX I. http://portal.anvisa.gov.br/wps/wcm/connect/c030c1004b541d58b5b8b7af8fded4db/Carta+ao+Cliente.pdf?MOD=AJPERES

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
    1137
  • Date
    2012-05-21
  • 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
    To date, there are no records in the NOTIFISA system. Anvisa is following this action.
  • Reason
    Possible impairment in the sterility barrier. the use of products in this condition results in a potential increase in the risk of infection.
  • Action
    SEE ORIENTATIONS IN THE LETTER TO THE CUSTOMER IN ANNEX. http://en.wikipedia.org/w/index.php?title

Device

Stapler Roticulator Disposable Auto Suture - Record: 10349000055 - Lots Affected - SEE NO ANNEX I...

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