Events

Retiro De Equipo (Recall) de Cook Bush SL and Bush DL Ureteral Illuminating Catheters(used for trans-illumination of the ureters during laparoscopic or open surgical procedures)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por William A Cook 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-00365-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-03-10
  • 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-00365-1
  • 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
    There has been an increase in reports that the proximal black component that connects to the distal transparent component of the catheter may overheat and melt. there have been no reports of overheating along the transparent component of the catheter, which is the part of the device that comes into contact with the patient’s urethra, bladder and ureter. potential adverse events that may occur if these devices overheat and come into direct contact with skin include burns to the skin.
  • Acción
    Customers are advised to quarantine and immediately return any affected product that remains unused to Cook Medical.

Device

Cook Bush SL and Bush DL Ureteral Illuminating Catheters(used for trans-illumination of the urete...
  • Modelo / Serial
    Cook Bush SL and Bush DL Ureteral Illuminating Catheters(used for trans-illumination of the ureters during laparoscopic or open surgical procedures)Cook Bush SL Ureteral Illuminating Catheter Set Catalogue Numbers: 084100, 084120 , J-BICS-058020Part Numbers: G16745, G16746, G16737All LotsCook Bush DL Ureteral Illuminating Catheter Set Catalogue Numbers: 084520, 084510, J-BICS-078000Part Numbers: G16747, G16143, G16262All LotsARTG Number: 215910
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd