Events

Rappel de Karl Storz Tissue Morcellation 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 Karl Storz Endoscopy 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-2015-RN-00310-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-04-14
  • 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-00310-1
  • 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
    Karl stoz is undertaking update of the karl storz tissue morcellation system instructions for use (ifu) by adding new ‘contraindications’ and ‘warnings’ .In 2014, the united states food and drug administration issued it’s ‘immediately in effect guidance document: product labelling for laparoscopic power morcellators’. karl storz submitted a morcellator labelling change request and after receiving the fda’s approval have now implemented the changes. the update to the ifu is in line with the the tga’s safety advisory about the laparoscopic power morcellators on august 4, 2014 which is available at https://www.Tga.Gov.Au/alert/laparoscopic-power-morcellators-update-4-august-2014 .
  • Action
    Karl Storz is informing the customers of the new ‘Contraindications’ and ‘Warnings’ in the IFU and providing them with a link to the new IFU. This action has been closed-out on 9/08/2016.

Device

Karl Storz Tissue Morcellation System

Manufacturer

Karl Storz Endoscopy Australia Pty Ltd