Events

Alerte De Sécurité sur Staples, Staplers and Staples with Stapler

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Covidien || Covidien Medical Products (Shanghai) Manufacturing Llc || Covidien Deutschland Manufacturing Gmbh || 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
    R1705-163
  • Numéro de l'événement
    2013DM-0010508
  • Date
    2017-05-09
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=89
  • Notes / Alertes
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Notes supplémentaires dans les données
  • Cause
    The manufacturer states that there is the possibility of an incomplete seal on the inner packaging, which may lead to premature degradation of the suture material, the use of products with this condition may increase the suture rupture potential, however this packaging defect does not affect the sterility of the product, leading to the occurrence of possible adverse events on the patient.

Device

Staples, Staplers and Staples with Stapler
  • Modèle / numéro de série
  • Description du dispositif
    The reusable staplers have applications in abdominal, gynecology, pediatric and thoracic surgery for resection, cross-sectional and anastomosis creation. They can be used for transverse cutting and resection of the pancreas. The recharge of a solouso has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and the creation of anastomosis. They can be used for transection and resection of the pancreas.
  • Manufacturer
    Covidien || Covidien Medical Products (Shanghai) Manufacturing Llc || Covidien Deutschland Manufacturing Gmbh || Covidien Llc

Manufacturer

Covidien || Covidien Medical Products (Shanghai) Manufacturing Llc || Covidien Deutschland Manufa...
  • 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
    NIDFSINVIMA