Events

Safety Alert for biodegradable and non-biodegradable esophageal stents system

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Ella-Cs, S.R.O.

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
    I1703-95
  • Event Number
    2013DM-0010471
  • Date
    2017-03-13
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=97
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer has identified reports that the depth stop dbs is not fixed correctly to the electrode, the analysis of the returned products indicates that the threaded area of the depth deltope screw was not large enough to allow the electrode to be fixed in the depth stop , so that the electrode slid through the stop, leading to possible adverse events on patients.

Device

biodegradable and non-biodegradable esophageal stents system
  • Model / Serial
  • Product Description
    For the treatment of esophageal strictures: - Treatment of malignant esophageal stenoses when conventional surgery is contraindicated. -treatment of benign esophageal stenoses that do not respond to standard therapy -the treatment of fistulasesofagorespiratory.
  • Manufacturer
    Ella-Cs, S.R.O

Manufacturer

Ella-Cs, S.R.O