Events

Rappel de Cook Multi-Use Holmium Laser Fibers

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par William A Cook 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-2017-RN-00696-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-05-30
  • 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-2017-RN-00696-1
  • 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
    The reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection and sterilisation of these products. in addition, the monitoring of chemical residues was not considered in the reprocessing validation. preliminary investigation indicates that validation data related to the reprocessing of these devices do not meet the current guidelines. potential adverse events that may occur if the products are not adequately reprocessed include urological infections and systemic infections from a urological origin as well as events resulting from chemical residual exposure. to date, there have been no reports of adverse reactions related to inadequate cleaning, disinfection, sterilisation or chemical residual exposure associated with these devices.
  • Action
    Cook Medical will be updating the reprocessing instructions in the Instructions For Use (IFU). In the interim, users are advised to quarantine any affected products. Use of the affected products can be continued if the updated "Suggested Fiber Reprocessing Instructions" provided is adhered to.

Device

Cook Multi-Use Holmium Laser Fibers
  • Modèle / numéro de série
    Cook Multi-Use Holmium Laser FibersCatalogue Identifiers: HLF-M273-H30, HLF-M365-H30, HLF-M550-H30, HLF-M940-H30, HLF-M273-HSMA, HLF-M365-HSMA, HLF-M550-HSMA & HLF-M940-HSMA Part Numbers: G23668, G23667, G23666, G23665, G25298, G25299, G25300 & G25301 (respectively)All LotsARTG Number: 209642
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd