Events

Retiro De Equipo (Recall) de Sureclip and Sureclip Plus Haemostasis Clips (Gastrointestinal endotherapy clip applier) Hemoclip 90 degree/5mm/12mm(max) rotatable/relocatable (x10/box) Hemoclip 90 degree/8mm/17mm(max) rotatable/relocatable (x10/box)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por CK Surgitech 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-00181-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-02-15
  • 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-00181-1
  • 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
    Ck surgitech has been notified of an incident concerning one of the above products. the device proved hard to fire, and upon deployment, detached a 10cm piece of wire that was removed through the scope with biopsy forceps. there is a risk of tissue puncture as a result of the issue.As a result, ck surgitech is recalling both the standard sureclip and the sureclip plus until investigations have been undertaken.
  • Acción
    CK Surgitech is advising users to inspect stock and quarantine affected units. Affected stock will be replaced or an alternative product supplied.

Device

Sureclip and Sureclip Plus Haemostasis Clips (Gastrointestinal endotherapy clip applier) Hemoclip...
  • Modelo / Serial
    Sureclip and Sureclip Plus Haemostasis Clips (Gastrointestinal endotherapy clip applier)Hemoclip 90 degree/5mm/12mm(max) rotatable/relocatable (x10/box)Product Code: ROCC-D-26-230-CLot Number: 150625231Expiry Date: 24/06/2018Hemoclip 90 degree/8mm/17mm(max) rotatable/relocatable (x10/box)Product Code: ROCC-F-26-230-CLot Number: 151115231Expiry Date: 15/11/2018ARTG Number: 261692
  • Manufacturer
    CK Surgitech Pty Ltd

Manufacturer

CK Surgitech Pty Ltd