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-2018-RN-00500-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-05-17
  • 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-2018-RN-00500-1
  • 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
    In march 2017, device technologies australia (dta) in conjunction with intuitive surgical sent correspondence (tga ref rc-2017-rn-00440-1) highlighting the proper use of the da vinci xi endowrist stapler release kit (srk) tool and providing additional information regarding the use of the instrument release kit (irk) tool as a backup if a srk tool was not available.Further to this, intuitive surgical has now developed an improved da vinci xi endowrist stapler release kit (srk) tool, which reduces the likelihood of breakage. please note that the instructions for use (ifu) remain the same.
  • Acción
    Device Technologies are advising they will be providing users with replacement SRK tool(s) of the new design. Two new SRK tools will be provided free of charge for each da Vinci Xi or da Vinci X customer using the EndoWrist Stapler system. Users should place all new SRK tools with their system and discard any previous versions in inventory. Additional SRK tools may be ordered via the standard ordering process. Users are reminded to refer to the IFU for appropriate use of the device.

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 KitObsolete Product Code: INS-381215New Product Code: INS-381215-03Part Number: 381215-02ARTG Number: 228401(Device Technologies Australia - Wrench, surgical)
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd