Events

Recall of BiCision (electrosurgical thermofusion and dissection system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Rymed 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-2013-RN-00186-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-02-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00186-1
  • 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
    Internal investigations found very few bicision instruments with the quality issue of low closing force of the jaw, which under unfavourable conditions could lead to insufficient thermofusion of large vessels or tissue bundles.This recall action was carried out prior to review by the tga.
  • Action
    Rymed is advising users to remove all affected devices from use. Return all affected devices to Rymed for credit or replacement when available.

Device

BiCision (electrosurgical thermofusion and dissection system)
  • Model / Serial
    BiCision (electrosurgical thermofusion and dissection system)Lot / serial numbers: W3174973WO182954W3177733W3177734W3179128WN189444W3176581WN189947ARTG Number: 94173
  • Manufacturer
    Rymed Pty Ltd

Manufacturer

Rymed Pty Ltd