Events

Retiro De Equipo (Recall) de 8 mm Fenestrated Bipolar Forceps used with da Vinci Standard System (IS1200)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies 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-00539-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-05-29
  • 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-00539-1
  • 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 customer complaints regarding dislodged cautery plug inserts which prevents a bipolar cautery cable from being properly connected to the instrument, resulting in loss of cautery function of the bipolar instrument. the dislodged cautery plug insert most commonlyoccurs prior to the commencement of a procedure, but may be noticed when connecting or disconnecting the bipolar cautery cable during the procedure.
  • Acción
    Customers are asked quarantine any affected stock and return them.

Device

8 mm Fenestrated Bipolar Forceps used with da Vinci Standard System (IS1200)
  • Modelo / Serial
    8 mm Fenestrated Bipolar Forceps used with da Vinci Standard System (IS1200) Product code: INS-400172Lot numbers: M10120815, M10120817, M10120831, M10120913, M10120918, M10121008, M10121024, M10121120, M10121123, M10121203, M10121210, M10121215, M10130220, M10130222, M10130311, M10130315, M10130411ARTG Number: 132451
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd