Events

Retiro De Equipo (Recall) de HARMONIC ACE + Shears with Adaptive Tissue Technology

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical 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-00446-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-05-07
  • 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-00446-1
  • 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
    Through post-market surveillance efforts and through an internal investigation, the manufacturer ethicon, have confirmed that some devices contained in these lots may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.To date, ethicon has not received any reports of adverse events associated with this issue.No other lots of the harmonic ace+ devices (other than those listed) and no other harmonic products are affected by this action.
  • Acción
    Johnson & Johnson are advising customers to inspect devices in their possession to determine if their facility has affected product. Customers should then follow the instructions provided in the Acknowledgement Form provided with the Customer Letter to arrange return of affected product.

Device

HARMONIC ACE + Shears with Adaptive Tissue Technology
  • Modelo / Serial
    HARMONIC ACE + Shears with Adaptive Tissue TechnologyProduct Code: HAR23 and HAR231Lot Numbers: P9125C, P94C8R, P94G1W, P9125C, P9125C, P94C8R, P94G1W, P9125CARTG Number: 118011(Johnson & Johnson Medical - Electrode, electrosurgical, active, ultrasonic/mechanical vibration, single-use)
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd