Events

Safety Alert for unkown device

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

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
    I1605-218
  • Event Number
    2009DM-0003684
  • Date
    2016-05-25
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=139
  • 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 detected that when the device is connected to a source of gas supply and the user makes it work in high performance mode (40 l / min, a15 mmhg), the flow drops to 0 l / min, activating the visual alarm " check the gas supply "on screen and immediately the insufflation stops, which could lead to potential adverse events on the patients and delays in the surgical procedures.

Device

unkown device
  • Model / Serial
    620-040-600, 620-040-601, 620-040-602, 620-040-604, 620-040-610, 620-040-611, 620-040-613, 620-040-614, specific serials .
  • Product Description
    This equipment is indicated to distend or expand cavities by insufflating CO2 during diagnostic laparoscopy and / or therapy in order to increase visibility during these procedures.
  • Manufacturer
    Stryker Endoscopy

Manufacturer

Stryker Endoscopy
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    NIDFSINVIMA