Events

Rappel de VueOptic Visualisation Source & Flexor Vue Deflecting Endoscopic System

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-00695-1
  • 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-00695-1
  • 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.(please note that for the endoscopic system, the reprocessing instructions apply to the vueoptic visualisation source as the flexor 180 is intended for one-time use only).
  • 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 "Reprocessing Instructions" provided is adhered to. (Users are to note that the reprocessing instructions apply to the VueOptic Visualisation Source as the Flexor 180 is intended for one-time use only).

Device

VueOptic Visualisation Source & Flexor Vue Deflecting Endoscopic System
  • Modèle / numéro de série
    VueOptic Visualisation Source & Flexor Vue Deflecting Endoscopic SystemVueOptic Visualisation Source Catalogue Identifier: FVO-150Part Number: G25343Flexor Vue Deflecting Endoscopic System Catalogue Identifiers: FV-090075-150 & FV-090045-150Part Numbers: G50972 & G34306 (respectively)All Lot NumbersARTG Numbers: 211575 and 211572
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd