Events

Safety Alert for HIGH FLOW INSULATOR AND PNEUMOSURE ACCESSORIES. Registration ANVISA: 80005430157. Models: 620-040-600 and 620-040-610. Serial No. of Products Affected: 0804CE394 through 0810CE295.

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
    960
  • Date
    2009-03-17
  • 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 potential effects of the problem are as follows: (a) Delay in surgery caused by the need to restart the insufflator; (b) Delay in surgery caused by need of replacement of the insufflator; (c) If the shut-down occurs and there is no alternative equipment available, there is a risk that the surgery will need to be converted into open surgery; and (d) if the device shuts off during surgery, there is a risk of accidental cutting of the patient's internal organs. Stryker do Brasil Ltda informed that, between January 13 and 16, 2009, the PneumoSure software was updated on all customers affected by the problem. For more information, access the Letter to Product Users (available at www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2009/960_carta.pdf). UTVIG / ANVISA is following up on this case.
  • Reason
    Sudden equipment shutdown may occur. the equipment can be reconnected, but with the risk of recurrence of the fault at any time.
  • Action
    The recommended actions for product users are as follows: (1) Check if there is any equipment in your inventory that is affected by this alert; (2) If you locate any affected equipment, check if it has already been corrected in relation to the problem mentioned (check the maintenance records - if you have any questions, contact the registry owner); (3) If the affected equipment has not yet been corrected, segregate it immediately, identifying it properly (with a poster, for example) to prevent inadvertent use of the equipment until the problem is corrected; (4) Contact the record holder (see address in the Manufacturer's description field) and report the existence of equipment at risk.

Device

HIGH FLOW INSULATOR AND PNEUMOSURE ACCESSORIES. Registration ANVISA: 80005430157. Models: 620-040...

Manufacturer

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