Events

Alerte De Sécurité sur UPDATE - LOADING FOR STACKER WITH REINFORCEMENT - DUET TRS - Registration 10349000298 - Straight Load Model Duet TRS 45 3,5mm (DUET4535); Straight Load Duet TRS 45 4.8mm (DUET4548) Lots Affected SEE CUSTOMER MENU UPDATED !. http://news.wikia.com/wiki

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 AUTO SUTURE DO BRASIL.

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
    1109
  • Date
    2012-01-30
  • 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
    Covidien claims to have received three (3) reports of fatalities and thirteen (13) serious adverse events as a consequence of the application of the Reinformer Stapler Charge - DUET TRS to the thoracic cavity. They concluded that Duet has the potential to injure adjacent anatomical structures within the thorax and may result in potentially fatal postoperative complications. Loaders for Reinforcing Stapler - DUET TRS should not use the device for thoracic surgeries, both in adult and pediatric patients. Covidien will review the DUET TRS Instructions for Use against contraindications for thoracic procedures in adult and pediatric patients. In order to guarantee patient safety, it has begun the collection to suit the Usage Instructions. This payment applies to the Reinforcing Stapler Charge - DUET TRS and only for use of this product in the thoracic cavity. Other families of Staplers and Endo GIA loads were unaffected. No cases have been reported in Brazil. ANVISA follows this action. #### UPDATE: 03/29/2012 - The company presents the conclusions of the corrective measures implemented as Amended Instructions for Use and published in DOU, as well as the collection of 24 of the 88 pieces sold. Also presents a Letter to the Client in Annex with relevant clarifications. #### UPDATE: 08/24/2012 - GENERAL COLLECTION OF THE PRODUCT. SEE CLIENT LETTER UPDATED IN ANNEX. ####
  • Cause
    Potential to injure adjacent anatomical structures within the thorax and abdomen and which may result in potentially fatal postoperative complications.
  • Action
    Users must immediately suspend product use, inventory inventory, identify and segregate affected products. The holder of the registration in Brazil will arrange the collection.

Device

UPDATE - LOADING FOR STACKER WITH REINFORCEMENT - DUET TRS - Registration 10349000298 - Straight ...

Manufacturer

AUTO SUTURE DO BRASIL
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA