Events

Retiro De Equipo (Recall) de Various surgical instruments actuated by the da Vinci Si Single Site Grip Release mechanism

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-2015-RN-01110-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-11-16
  • 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-2015-RN-01110-1
  • 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
    Under rare circumstances, grip actuated instruments may become fixed in a closed position. this potential failure has been attributed to excessive force exerted on the instrument during insertion into a curved cannula, which may result in: 1. a break in the roll gear and/or instrument shaft 2. damage to the push/pull mechanism that controls grip opening and closingif a da vinci si single-site instrument grip cannot be released normally or by opening the masters or the instrument release kit (irk), the surgeon may need to excise tissue in order to extract the instrument.
  • Acción
    The customer is to inspect and remove any instrument that shows signs of damage. If the instrument grips remain closed on tissue during surgery and the IRK cannot be used, the surgeon is to follow the instructions in the User Manual addendum to manually release the grip. The sponsor is to arrange the return of the product and credit. This action has been closed-out on 18/04/2017.

Device

Various surgical instruments actuated by the da Vinci Si Single Site Grip Release mechanism

Manufacturer

Device Technologies Australia Pty Ltd