Events

Safety Alert for Scalpel System

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Ethicon Endosurgery Inc || Ethicon Endosurgery S.A. De C.V. || Ethicon Endosurgery Llc.

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
    I1803-198
  • Event Number
    2012DM-0008445
  • Date
    2018-03-22
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=51
  • 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

Device

Scalpel System
  • Model / Serial
    GEN11, all serials.
  • Product Description
    The scalpel system is indicated for soft tissue incisions, when a control of the hemorrhage and a minimal thermal injury is desired. The system can be used as an assistant or substitute for electrosurgery, laser and steel scalpel, in general interventions, pediatric plastic, gynecological, exposure to orthopedic structures, open and endoscopic interventions. Approve to extend the indication, for the reference HARMONIC FOCUS CURVED SHEARS to otolaryngological processes (ORL), thus: the curved scissors HARMONIC FOCUS are indicated for soft tissue incisions when you want to control the bleeding and minimal thermal injuries. The instruments can be used as a complement or substitute for electrosurgery, laser and scalpel in general, otorhinolaryngological structures (ENT), aesthetic, pediatric, gynecological, urological, exposure to orthopedic structures (such as spinal cord and joint space) and other open procedures.
  • Manufacturer
    Ethicon Endosurgery Inc || Ethicon Endosurgery S.A. De C.V. || Ethicon Endosurgery Llc

Manufacturer

Ethicon Endosurgery Inc || Ethicon Endosurgery S.A. De C.V. || Ethicon Endosurgery Llc