Events

Alerte De Sécurité sur Commercial Name: Clearify Endoscopes Lens Protector and Defroster Technical Name: Laparoscopy Instruments ANVISA Registration Number: 13000059001 Hazard Class: I Model Affected: 21-345

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 LTDA; Covidien LLC.

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
    2121
  • Date
    2016-10-07
  • 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
    There is no need for action with the patient. Patients who have received treatment with a Clearify Endoscope Lens Defroster and Protector affected by this recall should continue to be monitored according to standard practice. #### UPDATED ON 11/21/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Cause
    The purpose of this is to communicate that medtronic is voluntarily recalling item codes and specific production batches from our clearify ™ display system. this voluntary recall is being performed due to the potential compromise of the packaging, which can result in a rupture of the sterile barrier. the use of products with this defect in the packaging may increase the risk of infection. there were no reports of serious injuries associated with this problem.
  • Action
    Field Action Code FA Recall Clearify triggered under the responsibility of AUTO SUTURE DO BRASIL LTDA. Company will collect for later return to Medtronic Field Returns Department.

Device

Commercial Name: Clearify Endoscopes Lens Protector and Defroster Technical Name: Laparoscopy Ins...

Manufacturer

AUTO SUTURE DO BRASIL LTDA; Covidien LLC
  • 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