Events

Retiro De Equipo (Recall) de ReNew Reusable Tips (Scissors, Graspers and Dissectors)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por C R Kennedy & Co 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-01152-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-09-21
  • 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-01152-1
  • 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
    Microline surgical has received customer reports that the heat-shrink insulation tube of renew reusable scissor, grasper and dissector tips may split during autoclave sterilisation/re-sterilisation. if a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there is a potential for burn due to insulation failure.This issue is due to a malfunction related to the heat-shrink insulation tube that is located immediately proximal to the metal tip.
  • Acción
    1. Users are to complete and return the supplied response form to the sponsor, even if the affected goods are no longer in possession. 2. A CR Kennedy Representative will contact customers to: a. Provide directions to initiate an RMA (Returned Material Authorisation) for the return of the ReNew Reusable tips at your facility. b. Discuss the availability of ReNew Disposable Tips that are counterparts to the Reusable items (where applicable). c. Organise a credit for all product returns to customer accounts.

Device

ReNew Reusable Tips (Scissors, Graspers and Dissectors)
  • Modelo / Serial
    ReNew Reusable Tips (Scissors, Graspers and Dissectors)All Product CodesARTG Number 192108
  • Manufacturer
    C R Kennedy & Co Pty Ltd

Manufacturer

C R Kennedy & Co Pty Ltd