Events

Rappel de TOPAZ MicroDebrider Wand (used for ablation and microdebridment in the tendons of the ankles, knees and shoulders)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Smith & Nephew 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-00275-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-03-11
  • 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-00275-1
  • 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
    Topaz microdebrider wands has failed to meet shelf-life at the expiration date indicated on the product labels during internal functional testing. it has been found that saline may leak from the proximal end of the handle during use, and the spacer between the active and return electrodes may be displaced. this can potentially lead to the spacer being unintentionally retained in a patient, which may lead to a prolonged procedure time.
  • Action
    Smith & Nephew is advising users to discontinue use and return the affected product. Smith & Nephew will be able to provide users with alternate products. This action has been closed-out on 25/01/2017.

Device

TOPAZ MicroDebrider Wand (used for ablation and microdebridment in the tendons of the ankles, kne...
  • Modèle / numéro de série
    TOPAZ MicroDebrider Wand (used for ablation and microdebridment in the tendons of the ankles, knees and shoulders)Product Number: ACH4040-01All batches affectedARTG Number: 221504
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd