Events

Safety Alert for Insufflation Apparatus

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Karl Storz Gmbh & Co. Kg.

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
    R1710-514
  • Event Number
    2009DM-0003689
  • Date
    2017-10-30
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=66
  • 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 a labeling error where the referenced devices could have been identified with the part number "20400162s" when the one that truly corresponds is "20400161s", leading to possible confusions and delays in the procedures.

Device

Insufflation Apparatus
  • Model / Serial
    ENDOFLATOR tube with filter, lot 129241
  • Product Description
    Insufflation device serves for the measurement and control of both pressure and flow. It also serves for the recognition and surgical, laparoscopic, colonoscopic and thoracoscopic intervention.
  • Manufacturer
    Karl Storz Gmbh & Co. Kg

Manufacturer

Karl Storz Gmbh & Co. Kg