Events

Safety Alert for Estech surgical stabilization platform system

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

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
    A1501-34
  • Event Number
    2012DM-0009204
  • Date
    2015-01-21
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=187
  • 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 if the instructions for use (ifu) for the above systems are not followed, the stainless steel cable may break during use, a situation that may arise with the repositioning of the cable when it is tensioned, or when an excessive adjustment is made, and by corrosion when using a cleaning solution inadequately during decontamination, which can lead to potentially adverse events occurring on the patient.

Device

Estech surgical stabilization platform system
  • Model / Serial
    HERCULES 3 / 001-401-161 and HERCULES 360 / 001-401- 160, distributed since May 2011.
  • Product Description
    Instruments for cardiovascular surgical interventions used in heart surgery. They are specifically designed to provide stabilization, positioning, arterial isolation and cleaning of tissues or structures, improving visibility during surgery.
  • Manufacturer
    Endoscopic Technologies, Inc.

Manufacturer

Endoscopic Technologies, Inc.