Events

Retiro De Equipo (Recall) de THUNDERBEAT TB Series Hand Instrument (used in general, laparoscopic and endoscopic surgeries)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Olympus 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-2013-RN-01240-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-11-26
  • 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-2013-RN-01240-1
  • 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 manufacturer has received complaints of damage to the thunderbeat hand instruments during surgical procedures.These complaints involve the following or a combination of the following descriptions:- cracking and deforming of the thunderbeat probe tip/jaw- partial separation of the ptfe (teflon) pad- exposed metal part due to severe wear of the ptfe padprobe damage detected during surgery will trigger audible and visual generator alarms.
  • Acción
    Olympus Australia is providing additional user instructions on procedural techniques to prevent damage to the Thunderbeat hand instruments.

Device

THUNDERBEAT TB Series Hand Instrument (used in general, laparoscopic and endoscopic surgeries)
  • Modelo / Serial
    THUNDERBEAT TB Series Hand Instrument (used in general, laparoscopic and endoscopic surgeries) Multiple Models affectedARTG Number: 209954
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd