Events

Retiro De Equipo (Recall) de Matrix Surgical Laparoscopic Spatula with Cable (Active endotherapy device)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Matrix Surgical 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-2014-RN-00020-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-01-13
  • 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-2014-RN-00020-1
  • 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
    This is a follow up to an earlier recall (tga reference: rc-2012-rn-00637-3) where the insulation of a diathermy spatula appeared to have melted during use and that the patient sustained secondary site damage to their fallopian tube. the manufacturer has determined that the safest maximum operating level for the diathermy spatulas is 30 watts.
  • Acción
    Matrix Surgical is advising users to quarantine affected stock for return to Matrix Surgical for replacement or credit note. Updated Instructions for Use (IFU) will be provided to all users along with the newly supplied devices. This action has been closed-out on 11/02/2016.

Device

Matrix Surgical Laparoscopic Spatula with Cable (Active endotherapy device)
  • Modelo / Serial
    Matrix Surgical Laparoscopic Spatula with Cable (Active endotherapy device)Product Code: UFPS-133057Lot Numbers: 817101080, 8081106264Product Code: UFPS-133058Lot Numbers: 8191203108, 8191206116, 8191208096, 8191211137, 8191305131, 8191309178Product Code: UFPS-145058Lot Numbers: 8301012171, 4871304081, 830100357ARTG Number: 169175
  • Manufacturer
    Matrix Surgical Pty Ltd

Manufacturer

Matrix Surgical Pty Ltd