Events

Retiro De Equipo (Recall) de da Vinci Xi EndoWrist Stapler Release Kit (SRK)

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-2017-RN-00440-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-04-04
  • 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-2017-RN-00440-1
  • 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
    The manufacturer, intuitive surgical has received complaints where the srk tool has broken during use. it was determined that misinterpretation of instructions provided on the is4000 srk instruction card may result in damage of the tool. there have been three clinical cases where the endowrist stapler jaws would not open while clamped on tissue, the srk tool broke, and the stapler was excised using an alternative stapling device or other surgical intervention. the risk to health due to the srk tool breakage can range from the minor delay in surgery in order to locate and use a backup srk or instrument release kit (irk) tool, to extracting the clamped tissue from the stapler jaws, to the worst case scenario of the clamped tissue needing to be excised using an alternative stapling device or other surgical intervention. device technologies wish to reiterate the proper use of the srk tool, and to provide additional instructions in the scenario of srk tool damage.
  • Acción
    Device Technologies is advising users in the scenario where the SRK needs to be used, to follow all instructions as provided in the da Vinci Xi EndoWrist Stapler Instruments and Accessories User Manual Addendum and reiterated in the customer letter. If the SRK tool breaks, proceed with the instructions using the Instrument Release Kit (IRK) tool to finish manually unclamping the stapler and contact your Device Technologies representative to arrange for SRK return through the product complaints process.

Device

da Vinci Xi EndoWrist Stapler Release Kit (SRK)
  • Modelo / Serial
    da Vinci Xi EndoWrist Stapler Release Kit (SRK)Product Name: IS4000 EndoWrist Stapler 45 – Stapler Release KitProduct Code: INS-381215Part Number: 381215-02ARTG Number: 228401
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd