Events

Alerte De Sécurité sur HEM-O-LOK CLIPS (Reg. 80117580001); ENDOSCOPIC APPLICATOR AND HEM-O-LOK CLIPS (Reg. 80117580004); CLIPS DE TITÂNIO HORIZON (Reg. 80117580007). Products Affected: Lots produced until end of July 2008.

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 Weck Closures Systems.

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
    943
  • Date
    2008-10-08
  • 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
    The holder of the registration of the products in Brazil (Brasil Import Ltda.) Received from the manufacturer an alert reporting quality control failure in relation to some product packaging - the process of placing the staple cartridge in the blister caused damage in some packages, resulting in holes that compromise the sterility of the products. As a result of the problem, the registry holder, together with the authorized distributor of the product (TC Técnica Cirúrgica Ltda), decided to collect all lots of the products under risk marketed in Brazil. Brasil Import Ltda informed the Tecnovigilance Unit that it has already started sending letters of communication to its clients (see Attachment to Customers - http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta_943_carta.pdf) .
  • Cause
    Possibility of holes in the packaging of the staples, which can compromise the sterility of the products.
  • Action
    The company that owns the product registrations in Brazil (Brasil Import Ltda.) Informed the Anvisa Tecnovigilance Unit (UTVIG / ANVISA) that it suspended the sale and is collecting all the batches of the mentioned products from the market (see Product Description field). The actions recommended to users and distributors of the products are as follows: (a) Check your stock and immediately stop the use / distribution of products at risk; (b) Segregate the products at risk, identifying them correctly to avoid inadvertent use; (c) Return the affected products to the distributor TC Técnica Cirúrgica Ltda (Rua Alberto Folloni 1040 - Bairro Ahú - CEP: 80540-000 - Curitiba / PR); (d) The Stock Status Report and Recognition Form for the aforementioned products must be sent to TC Técnica Cirúrgica Ltda through FAX (41) 3302-2133, even if the affected product is not found in stock.

Device

HEM-O-LOK CLIPS (Reg. 80117580001); ENDOSCOPIC APPLICATOR AND HEM-O-LOK CLIPS (Reg. 80117580004);...

Manufacturer

Weck Closures Systems
  • Source
    ANVSANVISA