Events

Safety Alert for electrosurgical arthroscopy electrode kits Conmed

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

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
    R1609-400
  • Event Number
    2008DM-0002629
  • Date
    2016-09-23
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=121
  • 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 it has detected damage to the insulation of the electrode rod, which could cause burns, leading potentially to serious adverse events to patients.

Device

electrosurgical arthroscopy electrode kits Conmed
  • Model / Serial
    CONCEPT HEATWAVE CS-023, specific lots manufactured between September 1, 2011 and 17 || November 2015
  • Product Description
    These electrodes are used in arthroscopic procedures to cut and coagulate soft tissues.
  • Manufacturer
    Conmed Corporation

Manufacturer

Conmed Corporation