Events

Retiro De Equipo (Recall) de ConMed Hyfrecator 2000 Electrosurgical Unit and Accessory Packages containing Handpiece Sheaths

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por ConMed Linvatec 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-00293-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-02-28
  • 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-00293-1
  • 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
    Conmed has identified that accessory packages contained within the hyfrecator 2000 carton were packaged in error by the manufacturer, with non-sterile handpiece sheaths (ref. 7-796-19) packaged in pouches that were labelled “sterile”. this could cause an end user to use a non-sterile sheath as if it were sterile. conmed has not received any reports that this mislabelling has resulted in injury or illness. only sheaths supplied in the original accessory package of affected hyfrecator cartons are mis-labelled.
  • Acción
    ConMed is advising customers who have an affected Hyfrecator 2000 still in its original sealed carton (unopened) to return the product to ConMed for replacement. Customers who have an out-of-carton (opened) Hyfrecator 2000 are to check if they have any remaining sheaths (Ref. 70796-19) of the affected lots and to return unused affected sheaths for replacement.

Device

ConMed Hyfrecator 2000 Electrosurgical Unit and Accessory Packages containing Handpiece Sheaths
  • Modelo / Serial
    ConMed Hyfrecator 2000 Electrosurgical Unit and Accessory Packages containing Handpiece SheathsConMed Hyfrecator 2000 Electrosurgical UnitReference Number: 7-900-230Multiple Serial NumbersAccessory Package containing Handpiece SheathsReference Number: 7-796-19 Lot Numbers: 201511234, 201512074, 201512094, 201601064, 201603284ARTG Number: 130647
  • Manufacturer
    ConMed Linvatec Australia Pty Ltd

Manufacturer

ConMed Linvatec Australia Pty Ltd