Events

Retiro De Equipo (Recall) de M320 Microscope Systems Article

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Leica Microsystems 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-00652-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-06-05
  • 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-00652-1
  • 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
    Internationally, three complaints were reported involving mechanical part failures for the leica m320 microscope system. these specific systems had failures with the screws that hold the gas spring fixation bracket in place . due to this failure, the gas spring, which is fixed to the upper part of the parallelogram, cannot hold up the weight of the optics carrier. this may potentially cause the m320 optics carrier to drop to the lower mechanical end stop.This failure was identical in all three complaints and has been linked to an identified batch of screws, used in the manufacture of the gas spring fixation bracket. these screws have been determined to be non-conforming. in the event that this observed defect were to occur, the m320 optics carrier may unintentionally drop into the surgical field, risking contact with the patient.
  • Acción
    Leica is advising they will contact affected users to arrange replacement of the mechanical parts of the parallelogram for all M320 microscopes manufactured with screws from the nonconforming batch.

Device

M320 Microscope Systems Article
  • Modelo / Serial
    M320 Microscope Systems Article/Catalogue Numbers: 10448419, 10448420, 10448485 and 10448486 Manufactured between 18 May 2014 and 21 January 2015.ARTG: 137683LEICA MICROSYSTEMS - Microscope, surgical,
  • Manufacturer
    Leica Microsystems Pty Ltd

Manufacturer

Leica Microsystems Pty Ltd