Events

Safety Alert for VISION STRYKER SURGICAL REFLECTOR. Registro Anvisa n ° 80005439007 .. Products affected: all serial numbers belonging to the codes (product codes) described in the annex http://portal.anvisa.gov.br/wps/wcm/connect/f933b60048c63f1dae8eafa3f2835ae8/Alerta_1097_Carta_aos_clientes.pdf? MOD = AJPERES.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Stryker do Brasil Ltda.

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
    1097
  • Date
    2011-10-21
  • 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
    According to information received by the UTVIG, there are 25 units potentially affected by the problem in Brazil. In its risk assessment for the case, the company has presented some potential hazards and damages that may result from nonconforming installations: loss of video signal, non-operation of the failure latches and overheating of light cranks (which may system components, such as flexible arms, surgical lights, flat panels, etc.). According to the company, the probability of occurrence of such events is remote and no related adverse events have been reported to the company so far. #### UPDATE - 10/01/2012 - The company forwarded file 0037019 / 12-3 , where he reports the completion of the field action, and all clients were informed. ####
  • Reason
    Documentation regarding product installations is incomplete or inadequate.
  • Action
    Stryker do Brasil Ltda reported that it has already begun to communicate to customers who own the equipment. Health care facilities that have affected equipment should schedule an inspection with Stryker, to verify the situation of the equipment installed and to prepare appropriate documentation.

Device

VISION STRYKER SURGICAL REFLECTOR. Registro Anvisa n ° 80005439007 .. Products affected: all seri...

Manufacturer

Stryker do Brasil Ltda
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    ANVSANVISA