Events

Safety Alert for Video laryngoscope GLIDESCOPE

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Verathon Medical.

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
    I1507-297
  • Event Number
    2010DM-0005379
  • Date
    2015-07-21
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=176
  • 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 states that it has detected through simulated compatibility limitations of sheets referenced when using certain cleaning agents (asp of cidex opa, metrex metricide plus 30 and sterisrevital-ox resert hld), in the same way to decided to exclude as cleaning agents sodium hypochlorite (bleach), isopropyl alcohol solution and hydrogen peroxide 7.5%, leading to potential deviations from the process of cleaning and disinfection of the leaves, which can lead to adverse adverse events on the patient.

Device

Video laryngoscope GLIDESCOPE
  • Model / Serial
    reusable sheets references AVL2, AVL3, AVL4, AVL5, GVL3, GVL4, GVL5, specific serials.
  • Product Description
    For intubation.
  • Manufacturer
    Verathon Medical

Manufacturer

Verathon Medical