Events

Retiro De Equipo (Recall) de Endo Wrist One Vessel Sealer (INS-410322) for the da Vinci Si (IS3000) Surgical System(Single use active endotherapy device used in endoscopic procedures for cutting and or coagulating tissue)

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-2014-RN-01174-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-11-04
  • 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-01174-1
  • 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
    - during a surgical procedure, if the blade does not return to its original position within a specified timeframe, the system determines the instrument has an “exposed blade”. the da vinci si system is designed to display a recoverable fault when an “exposed blade” error occurs. a recoverable fault means that you may continue using the system after addressing the error. activating and firing the knife blade while the jaws are more than 4 mm open increases the likelihood of an exposed blade error. currently, the vessel sealer applies bipolar energy between the electrode surfaces on the interior surface of the instrument jaws in order to coagulate vessels up to 7 mm in size. users are then instructed to keep the master grips fully closed during the sealing cycle. opening the grip on the masters reduces the pressure applied to the vessel during sealing, which may result in insufficient sealing performance.
  • Acción
    Device Technologies Australia is informing their customers of the changes to the user manual to reduce the potential for exposed blade errors and providing a software upgrade to reduce the potential for insufficient sealing. Device Technologies Australia is informing the customers to continue using the Endo Wrist One Vessel Sealer. A Device Technologies Australia product specialist / technician will contact the customer and provide the updated User Manual and schedule the software upgrade which will be available in December 2014. This action has been closed-out on 18/07/2016.

Device

Endo Wrist One Vessel Sealer (INS-410322) for the da Vinci Si (IS3000) Surgical System(Single use...

Manufacturer

Device Technologies Australia Pty Ltd