Events

Rappel de Diego Elite Tubeset, Standard and Declog(sterile devices intended to provide irrigation and suction when used with the Diego Elite 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 Olympus 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-00142-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-01-31
  • 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-00142-1
  • 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
    A problem has identified a problem with the diego elite tubesets in which the internal shaft may become disengaged and cause the blade to stop spinning. if the drive shaft was to disengage during a procedure, the result may be a delay while the surgeon selects a replacement device. at this stage, no reports of injuries relating to the drive shaft disengagement have been received.
  • Action
    Olympus is advising users to cease use of any affected products and quarantine affected stock prior to their return. They are further advised to contact Customer Service to arrange for issue of credit or replacement stock.

Device

Diego Elite Tubeset, Standard and Declog(sterile devices intended to provide irrigation and sucti...
  • Modèle / numéro de série
    Diego Elite Tubeset, Standard and Declog(sterile devices intended to provide irrigation and suction when used with the Diego Elite system)Item Codes: TS100S and TS101DCMultiple Lot Numbers ARTG Number: 143268
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd