Events

Retiro De Equipo (Recall) de GastriSail" Gastric Positioning Device

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Covidien LLC.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    79154
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0640-2018
  • Fecha de inicio del evento
    2017-09-21
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161500
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Tubes, gastrointestinal (and accessories) - Product Code KNT
  • Causa
    Reports of gastric or esophageal perforation occurring in procedures where the gastrisail" gastric positioning device has been used.
  • Acción
    Medtronic sent an URGENT MEDICAL DEVICE RECALL letter dated September 20, 2017 to their customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to review inventory and notify firm if any product remains at their facility. Arrangements for product return would then be made. For questions or concerns can be directed to customerservice@Covidien.com

Device

GastriSail" Gastric Positioning Device
  • Modelo / Serial
    Product numbers: GPS36 (Pediatric) GPS40 (Adult)  Lot codes: E6J0001X E6J0002X E6J0003X E6J0004X E6J0005X E6J0006X E6J0007X E6J0008X E6J0009X E6J0010X E6J0011X E6J0012X E6J0013X E6J0014X E6J0015X E6J0016X E6J0017X E6J0018X E6J0019X E6J0020X E6K0001X E6K0002X E6K0003X E6K0004X E6K0005X E6K0006X E6K0007X E6K0008X E6K0009X E6K0010X E6K0011X E6K0012X E6K0013X E6K0014X E6K0015X E6K0016X E6K0017X E6K0018X E6K0019X E6K0020X E6K0021X E6K0022X E6K0023X E6K0024X E6K0025X E6L0001X E6L0002X E6L0003X E6L0004X E6L0005X E6L0006X E6L0007X E6L0008X E6L0009X E6L0010X E6L0011X E6L0012X E6L0013X E6L0014X E6L0015X E6L0016X E6L0017X E6L0018X E6L0019X E6L0020X E6L0021X E6M0001X E6M0002X E6M0003X E6M0004X E6M0005X E6M0006X E6M0007X E6M0008X E6M0009X E6M0010X E6M0011X E6M0012X E6M0013X E6M0014X E7A0001X E7A0002X E7A0003X E7A0004X E7A0005X E7A0006X E7A0007X E7A0008X E7A0009X E7A0010X E7A0011X E7A0012X E7A0013X E7A0014X E7A0015X E7A0016X E7A0017X E7A0018X E7A0019X E7B0001X E7B0002X E7B0003X E7B0004X E7B0005X E7B0006X E7B0007X E7B0008X E7B0009X E7B0010X E7B0011X E7B0012X E7B0013X E7B0014X E7B0015X E7C0001X E7C0002X E7D0001X E7D0002X E7D0003X E7D0004X E7D0005X E7D0006X E7D0007X E7D0008X E7D0009X E7D0010X E7E0001X E7E0002X E7E0003X
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    GastriSail" Gastric Positioning Device || Product Usage: || The GastriSail gastric positioning system is indicated for use in gastric and bariatric surgical procedures for the application of suction, decompression and to radially expand the stomach, to drain gastric fluids, to test for leaks, to provide visible and tactile delineation of the lesser curvature of the stomach and to serve as a sizing guide for gastric and bariatric procedures, such as sleeve gastrectomy.
  • Manufacturer
    Covidien LLC

Manufacturer

Covidien LLC
  • Dirección del fabricante
    Covidien LLC, 60 Middletown Ave, North Haven CT 06473-3908
  • 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
    USFDA