Events

Safety Alert for Generators of Electrosurgery 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 || Conmed Electrosurgery || Conmed Corporation || Consolidated Medical Equipment Company.

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
    R1705-154
  • Event Number
    2013EBC-0010649
  • Date
    2017-05-02
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=91
  • 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 are sold with an accessory package (esu), which contains two sterile hand pieces, p / n 7-796-19, it was determined that in the period understood between december 2, 2015 and january 3, 2017 , the accessories were packaged by the manufacturer in non-sterile bags that were labeled as "sterile", leading to possibly being contaminated by the use of non-sterile material and potentially presenting adverse events on the patients.

Device

Generators of Electrosurgery CONMED

Manufacturer

Conmed Corporation || Conmed Electrosurgery || Conmed Corporation || Consolidated Medical Equipme...