Events

Rappel de Procise EZ View with Integrated Cable(Electrosurgical electrode)

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 Surgical 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-2015-RN-00561-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-07-01
  • 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-2015-RN-00561-1
  • 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
    Smith & nephew surgical pty ltd. has initiated a recall of arthrocare corporation procise ez view with integrated cable wands, lot 1093290, due to a manufacturing inspection issue. affected lot of these devices have been released without meeting the dielectric specifications. in the event an affected wand is presented for surgery, the wand may develop a dielectric breakdown creating a small gap leading to arcing. this created arcing could lead to diminished ablation and coagulation performance and in rare instances a surgeon or patient burn. also, the decreased hemostasis resulting in injury or impairment could require additional medical intervention. to date there have been no reported adverse events related to this issue.
  • Action
    Customers are advised to immediately discontinue use of the affected lot and take steps to quarantine the device(s). Smith & Nephew Surgical will arrange for affected products to be returned and suggest alternate products. This action has been closed-out on 05/12/2016.

Device

Procise EZ View with Integrated Cable(Electrosurgical electrode)
  • Modèle / numéro de série
    Procise EZ View with Integrated Cable(Electrosurgical electrode)Product No.: EIC8875-01Lot Number: 1093290ARTG Number:221504
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd