Events

Alerte De Sécurité sur Bronchoscopy device. BF-P40, BF-P40, BF-P40, BF-P40, BF-P40, BF-P40, BF-P40, BF-P40, BF-1T160, BF-3C160, BF-XT160

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par OLYMPUS AMERICA INC.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    407
  • Date
    2002-03-06
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    1 - The Technoviglance Unit / ANVISA / MS, identified the following models: BF-160, BF-P160, BF-1T160, BF-240, BF-P240, BF-1T240, BF-40, BF-P40, BF-1T40, BF-XT40, BF-3C40, BF-XP40, are registered nationwide. And, it is doing business with the company to solve this problem. This solution should be extended to all users of these products in the national territory. In order to establish a proactive measure, contact your local representative as soon as the loosening is detected, to update the biopsy channel entrance port. For more information: Tecnovigilância-ANVISA Unit, by phone 0xx61-4481485 or 448.1331- email: tecnovigilância@anvisa.gov.br ----------------------- ----------------------------------------------- 11/04 / 2002 - MICRONAL representative in Brazil, reported the existence of 46 units of this product and has already begun detailed instructions on technical modification procedures (exchange of the portal of entry of the biopsy forceps). He also informed that it is foreseen for 06/03/2002 the conclusion of the "recall" program started on 03/21/2002. If you are one of the 46 customers who have purchased the product in question, and until this date, you have not contacted your representative, it can be done through telephonic (11) 5183 5100 or FAX (11). ) 5183 8333 or, http // www.micronal.com.br ---------------------------------- -------------------------------- 15/04/2002 - The unit of Tecnovigilâcia / ANVISA, is checking the information provided by the company, with regard to the technical procedures of modification (exchange of the portal of entry of the biopsy forceps) with some clients, it was verified that up to the present moment the corrective actions are being carried out in the models involved.
  • Cause
    Two patients died in baltimore and 400 others may be infected with a pseudomonas bacterium. the problem with the bronchoscope lies in the lateral entry component of the biopsy forceps where bacteria accumulate in this space. the equipment is usually sterilized with glutaraldehyde and this space would not be sufficiently disinfected. the accumulation of bacteria in the piece was noticed by a nurse in the state of tenessee. it was found that cultures of pulmonary secretions collected in the bronchoscopes in which they had space indicated almost always the presence of the bacterium called pseudomonas.
  • Action
    Epidemiologists in the medical department at Johns Hopkins Hospital and Vanderbilt University found that Olympus' bronchoscopes were the source of the problem and notified the company. The company issued the recall and advised the Food and Drug Administration (FDA). The alert has been sent to other departments. The manufacturer said it sent mail to 2,361 health centers, but admits that only 40% of the defective equipment was collected. The company initiated the actions by a questionnaire, and a second correspondence dated February 27, 2002. Check that you have received the correspondence from Olimpus with the questionnaire and the instructions recommended by the manufacturer. Make sure you have followed all labeled instructions for reprocessing your bronchoscope, whether manual or automatic. Use the following procedure 1 - Check the port of the biopsy channel to determine if there is any loosening. Step 01: Rotate the biopsy channel entrance door counterclockwise, if this movement is easy, the biopsy channel entrance door shows loosening. Step 02 - In this case, tighten the port of the biopsy channel, turning strongly in the hourly direction. HOW TO PROCEED: In all cases where the loosening is detected, the manufacturer requests that you return the affected bronchoscope to update the port of entry of the biopsy channel. Return all affected products to your local representative or directly to Olympus National Service Center, ATTN: Bronchoscope Modification; 2400 Ringwood Avenue, San Jose CA 95131-1700, USA

Device

Bronchoscopy device. BF-P40, BF-P40, BF-P40, BF-P40, BF-P40, BF-P40, BF-P40, BF-P40, BF-1T160, BF...

Manufacturer

OLYMPUS AMERICA INC
  • Source
    ANVSANVISA