Events

Safety Alert for Cisto Ureteroscope

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

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
    I1704-148
  • Event Number
    2008DM-0001767
  • Date
    2017-04-27
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=92
  • 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 certain types of forceps belonging to the accessories of rigid auxiliary instruments, can not be inserted into the corresponding probe channel of the referenced device, some can be inserted but with difficulty, the associated instrument are the grippers with decocodrilo jaws, 7 fr, model 86456508 and crocodile clamp grippers, 6 fr, model 89686808, this could lead to delays in the procedure or possible adverse events.

Device

Cisto Ureteroscope
  • Model / Serial
  • Product Description
    They serve for the visualization of the bladder, the urethra and the ureter through the natural orifice.
  • Manufacturer
    Meditec S.A.

Manufacturer

Meditec S.A.
  • Source
    NIDFSINVIMA