Events

Safety Alert for Ureterorenofibroscope Technical Name: Ureterorenofibroscope Registration Number ANVISA: 80124630193 Hazard Class: II Model Affected: URF-P6 / P6R Series Affected: 2613119,2613237,2613239,2612933,2612936,2612947,2112H189,2613101, 2612937, 2613240, 2613102,2613844,2613861,2613846,2613847,2613848,2613845,2613864,2613866.

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
    2201
  • Date
    2017-02-15
  • 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 of instructions for safe use of the equipment to mitigate all risks.
  • Reason
    Olympus medical systems corporation received customer complaints regarding the use of urf-v2 / v2r (not registered in brazil) there were reported 4 adverse events reported in the following countries: france / usa / canada / japan, all urf- v2 / v2r. due to the great similarity with the product urf-p6 / p6r (registered in brazil), it was determined that action was also for this model. the root cause was associated with rupture of the flexible tip, a rupture associated with unsafe use in the patient.
  • Action
    Field Action Code FA_148_05 triggered under the responsibility of the company Olympus Optical do Brasil Ltda. Company will update, correct or supplement the instructions for use.

Device

Ureterorenofibroscope Technical Name: Ureterorenofibroscope Registration Number ANVISA: 801246301...

Manufacturer

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