Events

Retiro De Equipo (Recall) de Procise EZ View with Integrated Cable(Electrosurgical electrode)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Smith & Nephew Surgical 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-2015-RN-00561-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-07-01
  • 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-2015-RN-00561-1
  • 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
    Smith & nephew surgical pty ltd. has initiated a recall of arthrocare corporation procise ez view with integrated cable wands, lot 1093290, due to a manufacturing inspection issue. affected lot of these devices have been released without meeting the dielectric specifications. in the event an affected wand is presented for surgery, the wand may develop a dielectric breakdown creating a small gap leading to arcing. this created arcing could lead to diminished ablation and coagulation performance and in rare instances a surgeon or patient burn. also, the decreased hemostasis resulting in injury or impairment could require additional medical intervention. to date there have been no reported adverse events related to this issue.
  • Acción
    Customers are advised to immediately discontinue use of the affected lot and take steps to quarantine the device(s). Smith & Nephew Surgical will arrange for affected products to be returned and suggest alternate products. This action has been closed-out on 05/12/2016.

Device

Procise EZ View with Integrated Cable(Electrosurgical electrode)
  • Modelo / Serial
    Procise EZ View with Integrated Cable(Electrosurgical electrode)Product No.: EIC8875-01Lot Number: 1093290ARTG Number:221504
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd