Events

Retiro De Equipo (Recall) de StoneBreaker Pneumatic Lithotripter and associated accessories StoneBreaker Pneumatic Lithotripter, StoneBreaker Exhaust Cap, StoneBreaker Exhaust Line, StoneBreaker Probe Cap, StoneBreaker Sterilization Cap, StoneBreaker CO2 Cartridge, StoneBreaker Single Use Probe

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-2018-RN-00268-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-03-28
  • 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-2018-RN-00268-1
  • 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
    Cook medical is initiating a recall of the stonebreaker pneumatic lithotripter and associated accessories. the product is intended for reprocessing at the user facility. cook medical has identified a number of issues relating to the instructions for use (ifu) which may affect the sterility of the device.- the interior of the product may not be sterilised to the appropriate sterility assurance level when following the reprocessing instructions provided in the instructions for use. - the co2 cartridge pouch may be susceptible to tearing.- the exhaust line (purchased separately) does not include re-processing instructions.- the o-ring in the handle may swell during use, leading to leakage and loss of power.Potential adverse events that may occur include urinary tract infection (uti), pyelonephritis, and urosepsis and device leaking and loss of power.
  • Acción
    Cook Medical is advising all users to cease use and quarantine the affected products. All affected product is to be returned to Cook Medical.

Device

StoneBreaker Pneumatic Lithotripter and associated accessories StoneBreaker Pneumatic Lithotripte...
  • Modelo / Serial
    StoneBreaker Pneumatic Lithotripter and associated accessoriesStoneBreaker Pneumatic Lithotripter, StoneBreaker Exhaust Cap, StoneBreaker Exhaust Line, StoneBreaker Probe Cap, StoneBreaker Sterilization Cap, StoneBreaker CO2 Cartridge, StoneBreaker Single Use ProbePart Numbers: SBL-KIT1, SBA-EC, SBA-EL, SBA-PC, SBA-SC, SBC-10, SBP-010500, SBP-010605, SBP-016500, SBP-016605, SBP-020425All Lot NumbersARTG Numbers: 203852 and 203319
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd