Events

Safety Alert for Commercial Name: Clearify Endoscopes Lens Protector and Defroster Technical Name: Laparoscopy Instruments ANVISA Registration Number: 13000059001 Hazard Class: I Model Affected: 21-345

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.

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
    2121
  • Date
    2016-10-07
  • 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
    There is no need for action with the patient. Patients who have received treatment with a Clearify Endoscope Lens Defroster and Protector affected by this recall should continue to be monitored according to standard practice. #### UPDATED ON 11/21/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Reason
    The purpose of this is to communicate that medtronic is voluntarily recalling item codes and specific production batches from our clearify ™ display system. this voluntary recall is being performed due to the potential compromise of the packaging, which can result in a rupture of the sterile barrier. the use of products with this defect in the packaging may increase the risk of infection. there were no reports of serious injuries associated with this problem.
  • Action
    Field Action Code FA Recall Clearify triggered under the responsibility of AUTO SUTURE DO BRASIL LTDA. Company will collect for later return to Medtronic Field Returns Department.

Device

Commercial Name: Clearify Endoscopes Lens Protector and Defroster Technical Name: Laparoscopy Ins...

Manufacturer

AUTO SUTURE DO BRASIL LTDA; Covidien LLC
  • 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