Events

Recall of Karl Storz Tissue Morcellation System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Karl Storz Endoscopy Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-00310-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-04-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00310-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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