Events

Safety Alert for Product: Endo Gia Ultra Universal Stapler. Model (s): EGIAUXL, EGIAUSTND and EGIAUSHORT. Anvisa Registry n ° 10349000302.

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; Covidien llc; Covidien.

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
    1794
  • Date
    2016-01-14
  • 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
    If the instrument does not fire or trip partially, or if the hinge lever loosens, the surgeon may need to replace the device to continue the procedure. According to the company, no injuries have been reported in patients who have been caused by these problems.
  • Reason
    1) instruments fail to fire or fire partially; and 2) disengagement of the articulating lever of the instrument during use occurs.
  • Action
    The product is being recalled. Unused products of affected item and batch codes must be returned as described in the Required Actions section of the company's customer alert message. If you have distributed the Endo GIA ™ Ultra Universal Stapler to other people or units, immediately forward the information in this alert and the company release to these recipients. All affected units must be returned. Company code for the field action: FAEGIA. Access the alert message to customers at: http://portal.anvisa.gov.br/wps/wcm/connect/e1cedb004b5205bf8841b8e16860cb38/Carta+ao+Client+1794.PDF?MOD=AJPERES

Device

Product: Endo Gia Ultra Universal Stapler. Model (s): EGIAUXL, EGIAUSTND and EGIAUSHORT. Anvisa R...

Manufacturer

AUTO SUTURE DO BRASIL LTDA; Covidien llc; Covidien
  • 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