Events

Retiro De Equipo (Recall) de Large and Mega Needle Driver Endowrist Instruments for da Vinci Surgical Systems

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-01294-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-12-09
  • 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-01294-1
  • 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
    Intuitive surgical has become aware of the potential for detachment of the jaw insert for large needle drivers and mega needle drivers. only large needle driver and mega needle driver instruments manufactured between july 2007 and october 2011 are affected. if a jaw insert detaches during surgery, this could result in a device fragment falling into the patient.
  • Acción
    Device Technologies is advising users to quarantine affected devices from use. Affected devices can be returned to Device Technologies.

Device

Large and Mega Needle Driver Endowrist Instruments for da Vinci Surgical Systems
  • Modelo / Serial
    Large and Mega Needle Driver Endowrist Instruments for da Vinci Surgical SystemsLarge Needle Driver, da Vinci S and da Vinci SiProduct Number: INS-420006Mega Needle Driver, da Vinci S and da Vinci SiProduct Number: INS-420194Large Needle Driver, da Vinci StandardProduct Number: INS-400006Mega Needle Driver, da Vinci StandardProduct Number: INS-400194.Multiple Lot Numbers affectedManufactured between July 2007 and October 2011ARTG Number: 146826
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd