Events

Safety Alert for Unit for Electrosurgery

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

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
    I1602-47
  • Event Number
    2009EBC-0004122 ; 2009EBC-00044427
  • Date
    2016-02-04
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=158
  • 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 states that the referenced equipment was equipped with the wrong bipolar pedal for the activation of its bipolar functions, reference fs-18 instead of the fs-23, when the equipment is used with the wrong pedal the main functions of the equipment are conserved, except the bipolar function that will present failures, leading to the potential generation of adverse events on patients or delays in surgical times.

Device

Unit for Electrosurgery
  • Model / Serial
    SS501-SX
  • Product Description
    Medical equipment capable of transforming electrical energy into heat in order to coagulate, cut or eliminate soft tissue.
  • Manufacturer
    Wem Equipos Electrónicos Ltda.

Manufacturer

Wem Equipos Electrónicos Ltda.
  • Source
    NIDFSINVIMA