Events

Retiro De Equipo (Recall) de Instructions For Use (IFU) - Sonopet Ultrasonic Products

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Stryker Australia Pty Ltd.

¿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
    RC-2018-RN-00323-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-04-19
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00323-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    The fda has recommended that device manufacturers add the following statement to product labelling for ultrasonic aspirators indicated for laparoscopic, open, or gynaecologic surgery:"contraindication: this ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids."given this, stryker is updating the ifu to include this for all sonopet ultrasonic products. all sonopet ultrasonic products manufactured after march 30, 2018 will include an already updated ifu.
  • Acción
    Stryker is advising customers that the current IFU is being updated to reflect the new contraindications. Users are to maintain awareness of the updated contraindication to ensure the device is not used for fragmentation, emulsification, and aspiration of uterine fibroids.

Device

Instructions For Use (IFU) - Sonopet Ultrasonic Products
  • Modelo / Serial
    Instructions For Use (IFU) - Sonopet Ultrasonic ProductsMultiple affected productsARTG numbers:174349 (Stryker Australia - Electrosurgical unit, ultrasonic/mechanical vibration)297743 (Stryker Australia Pty Ltd - Ultrasonic surgical system torque wrench, reusable)298249 (Stryker Australia - Electrode handpiece, electrosurgical, ultrasonic/mechanical vibration, foot-controlled)
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA