Events

Safety Alert for Duodenoscope Technical Name: Duodenoscope ANVISA Registration Number: 80124630021 Hazard Class: II Affected Model: TJF-145 / TJF-150

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Olympus Optical do Brasil Ltda.; Olympus Medical Systems Corp..

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
    2310
  • Date
    2017-06-05
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Extra notes in the data
    The customer letter describes the actions that Olympus is taking for this field action and informs the customer that the equipment can be used normally in the meantime. It also informs customers that they will continue to follow reprocessing and cleaning guidelines until they receive the new manual versions and the new MAJ-1534 cleaning brush.
  • Reason
    Olympus optical of brazil received a notification from olympus corporation of the americas regarding a voluntary global field action initiated by olympus medical systems corporation for the above referenced products. faced with the mitigation of client infection following procedures with the tjf-145 / tjf-150 duodenoscopes, olympus decided to increase the safety margin, review the reprocessing manual and include a new cleaning brush in the method.
  • Action
    Field Action Code FA_149_01 triggered under the responsibility of the company Olympus Optical do Brasil Ltda. Company will update, correct or supplement the instructions for use.

Device

Duodenoscope Technical Name: Duodenoscope ANVISA Registration Number: 80124630021 Hazard Class: I...

Manufacturer

Olympus Optical do Brasil Ltda.; Olympus Medical Systems Corp.