Events

Retiro De Equipo (Recall) de da Vinci Xi EndoWrist Stapler 45 Instrument

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-2016-RN-01111-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-22
  • 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-2016-RN-01111-1
  • 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
    There has been a field failure overseas with the da vinci xi endowrist stapler 45 instrument, where the stapler remained clamped on tissue even when the stapler release kit was used. intuitive surgical has determined that this issue is the result of a bearing failure within the housing of the instrument. the bearing failure is associated with components from a specific bearing supplier and, as such, is found only in certain lots of instruments.If the instrument cannot be released from tissue during a procedure, then the stapler and the tissue it is grasping may need to be excised using an alternative stapling device or other surgical intervention. failure of the bearing may also cause an interruption in shaft rotation, resulting in minimal delay in the surgery while the instrument is examined and replaced with a new one.
  • Acción
    Device Technologies is advising users to inspect their inventory and isolate any affected Endowrist Stapler 45 Instruments. Upon receiving notice of affected stock, Device Technologies will arrange for return of the instruments and provide replacement instruments. Opened Endowrist Stapler 45 Instruments are to be cleaned and sterilised before returning. This action has been closed-out on 11/05/2017.

Device

da Vinci Xi EndoWrist Stapler 45 Instrument
  • Modelo / Serial
    da Vinci Xi EndoWrist Stapler 45 InstrumentProduct Reference: IS4000 EndoWrist Stapler 45Product Code: INS-470298 Multiple Lot Numbers affectedARTG Number: 146826
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd