Events

Safety Alert for Trocar KII Access Systems

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

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
    R1706-214
  • Event Number
    2008DM-0003058
  • Date
    2017-06-09
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=83
  • 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 reports that the referenced devices may have compromised their sterility, leading to the potential occurrence of adverse events on patients.

Device

Trocar KII Access Systems
  • Model / Serial
  • Product Description
    The trocar KII access systems are indicated in laparoscopic interventions of general, abdominal, gynecological and thoracic minimally invasive surgery, with the purpose of establishing an insertion path or achieving access through tissue planes and / or potential spaces for endoscopic instruments. All components are made of latex-free materials. The trocar access systems are sterile and disposable devices for use in a single patient. Optical trocar access systems use an optical element to visualize the tissue layers during insertion; however, they can be used without visualization for primary or secondary inserts.
  • Manufacturer
    Applied Medical Resources

Manufacturer

Applied Medical Resources