Events

Notificaciones De Seguridad De Campo acerca de Endo GIA Auto Suture Universal Stapler

Según ALIMS (Agencija za lekove i medicinska sredstva), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Serbia que fue producido por Covidien LLC.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2015-12-15
  • Fecha de publicación del evento
    2015-08-02
  • País del evento
    Serbia
  • Fuente del evento
    ALIMSA
  • URL de la fuente del evento
    https://www.alims.gov.rs/latin/2016/02/08/obavestenje-o-povlacenju-medicinskog-sredstva-sa-trzista-3/
  • Notas / Alertas
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Notas adicionales en la data
  • Causa
    This corrective action is taken after customer reports that the instrument charge has not been fired or that a partial firing has occurred and that the movable linkage has been detached during use. if the charge of the instrument does not ignite or the ignition is partially fired or the movable joint is detached, it may be necessary for the surgeon to replace the medical device to continue the procedure.

Device

Endo GIA Auto Suture Universal Stapler
  • Modelo / Serial
    • EUGIASHORT – series: from P3C to P5B0289X; from P5C0196X to P5C0197X; from P5C0304X to P5C0307X; from P5C0796X to P5C0798X; from P5D0049X to P5D0051X; from P5D0146X to P5D0148X; from P5E0261X to P5E0262X; from P5F0158X to P5F0161X; N3F0260RX; N3F0266RX; N3F0267RX; P5C0201X; P5D0538X; P5E0680X; P5E0682X; P5E0686X; P5E0760X; P5E0762X; P5E0765X • EUGIAUSTND – series from P3C to P5B0521X; from P5D0410X to P5D0411X; from P5D0823X to P5D0829X; from P5E0080X to P5E0082X; from P5E0317X to P5E0320X; from P5E0322X to P5E0324X; from P5F0001X to P5F0002X; P5C0239X; P5C0241X; P5C0508X; P5C0510X; P5C0512X; P5C0597X; P5C0599X; P5C0601X; P5C0603X; P5C0684X; P5C0803X; P5C0805X; P5C0807X; 5PD0067X; 5PD0069X; 5PD0073X; 5PD0170X; 5PD0413X; 5PD0415X; 5PD0417X; 5PD0419X; 5PD0447X; 5PD0623X; 5PD0624X; 5PD0626X; 5PD0628X; 5PD0630X; 5PE0525X; 5PF0004X; 5PF0006X; 5PF0008X; 5PF0010X; 5PF0014X; 5PF0017X; 5PF0019X; 5PF0021X; 5PF0213X; 5PF0217X • EGIAUXL – series from P3C to P5B0454X; from P5C0152X to P5E0450X; P5B0468X
  • Manufacturer
    Covidien LLC

Manufacturer

Covidien LLC
  • 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
    ALIMSA