Events

Safety Alert for clip applicators for laparoscopy Direct Drive Clip

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
    R1604-152
  • Event Number
    2009DM-0004659
  • Date
    2017-04-12
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=93
  • 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 due to the increase in declining reports indicating the application of inconsistent clips, this failure can lead to malocclusion of the vessels, although malformed clips are easily evident to the user, leading to the occurrence of potentially adverse events on the patients.

Device

clip applicators for laparoscopy Direct Drive Clip
  • Model / Serial
    CA090 with expiration date prior to March 18, 2019, lots 1190181 through 1265006.
  • Product Description
    It is indicated for ligating vessels that, in the opinion of the surgeon, require a medium or large size ligature clip.
  • Manufacturer
    Applied Medical Resources

Manufacturer

Applied Medical Resources