Events

Alerta De Seguridad para Endo Peanut 5 mm Device

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Medtronic.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2017-05-19
  • Fecha de publicación del evento
    2017-05-19
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170520a.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: medtronic endo peanut 5 mm device medical device manufacturer, medtronic, has issued a medical device safety alert concerning its endo peanut 5 mm device. [item code: 173019; lot numbers: m5k04x to m7a01x; expiration: october 2020 through january 2022]. according to the manufacturer, the voluntary recall is being conducted following reports that the cotton tip of the device may disengage due to insufficient adhesive application during the manufacturing process. the use of products with this issue may increase the potential for the tip to disengage resulting in possible extension of operating room time or the need for unintended radiation exposure via x-ray for detection of the foreign body. while four reports indicate that patients required an intraoperative x-ray to locate the disengaged tip, and in one case the tip was not retrieved subsequent to x-ray, no patient injury or impairment has been reported. the manufacturer requests customers to quarantine and return any unused products.. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 may 2017.

Device

Endo Peanut 5 mm Device
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medtronic Endo Peanut 5 mm Device
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “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
    DH