Events

Rappel de PneumoSure XL High Flow Insufflator (Used to create a cavity by insufflating CO2 during diagnostics and/or therapeutic laparoscopy)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Stryker Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2016-RN-00392-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-04-04
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00392-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    An issue has been identified that when the affected device is operating with a flow setting of 18l/min or greater and connected to a house gas inlet source, within seconds of insufflating the flow rate would drop to 0l/min and the red “check gas supply” symbol would appear on the display, immediately suspending insufflation.The failure produced by the defective product is the red “check gas supply” error on the display that occurs when the insufflator has a flow setting of 18l/min or greater. during a procedure, this would result in pressure decrease in the abdomen. unclear image due to poor abdominal distention is the hazardous situation associated with low gas pressure during a procedure.
  • Action
    Stryker is advising users to inspect stocks and quarantine any affected units. A Stryker representative will contact the affected customers to arrange for the removal and replacement of the affected units. This action has been closed-out on 02/02/2017.

Device

PneumoSure XL High Flow Insufflator (Used to create a cavity by insufflating CO2 during diagnosti...
  • Modèle / numéro de série
    PneumoSure XL High Flow Insufflator (Used to create a cavity by insufflating CO2 during diagnostics and/or therapeutic laparoscopy)Catalogue Numbers: 0620040610, 0620040611, 0620040600Multiple Lot Numbers affectedARTG Number: 139712
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DHTGA