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. 의 안전성 경고

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.

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.