Events

Retiro De Equipo (Recall) de da Vinci Xi 5mm-8mm Universal Cannula Seal and da Vinci Xi 12mm & Stapler Universal Cannula SealUniversal Seals, 5mm-8mm

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-00701-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-06-23
  • 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-00701-1
  • 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
    Device technologies australia (dta) in conjunction with the manufacturer, is issuing this warning notice in relation to the use of da vinci xi 5mm-8mm universal cannula seal and da vinci xi 12mm & stapler universal cannula seal in all surgical procedures.During internal inspections, intuitive surgical has identified particulate in the insufflation stopcocks on the da vinci xi 5mm-8mm universal cannula seal. the particulate generated from the seal material has the potential to be introduced into the cannula lumen when insufflation is connected. there have been no injuries reported related to this issue.
  • Acción
    Users are advised to not use the da Vinci Xi 5mm-8mm Universal Cannula Seal or the da Vinci Xi 12mm & Stapler Universal Cannula Seal for insufflation, or open the stopcock during all types of surgical procedures until this issue is resolved. It is recommended to use an alternative device such as an angio-catheter, Veress needle or laparoscopic trocar for initial access and to maintain insufflation throughout all procedures as an alternative to insufflation through the da Vinci Xi 5mm-8mm Universal Cannula Seal (INS-470361) or the da Vinci Xi 12mm & Stapler Universal Cannula Seal (INS-470380). This action has been closed-out on 20/02/2017.

Device

da Vinci Xi 5mm-8mm Universal Cannula Seal and da Vinci Xi 12mm & Stapler Universal Cannula SealU...
  • Modelo / Serial
    da Vinci Xi 5mm-8mm Universal Cannula Seal and da Vinci Xi 12mm & Stapler Universal Cannula SealUniversal Seals, 5mm-8mmPart Number: INS-740361 Stapler Universal Cannula Seal, 12mm & StaplerPart Number: INS-470380ARTG Number: 181744
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd