Events

Recall of Conmed GS2000 - 50L Abdominal Insufflator(provides CO2 gas distension of surgical cavities via an endoscope, for diagnostic and/or operative endoscopy)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by ConMed Linvatec 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-2016-RN-01601-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-12-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01601-1
  • 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
    The reason for this recall is that the device could cause a patient overpressure situation without any visual or auditory indication or warning from the device. if specific conditions occur, the affected unit could create an overpressure which is transient and reversible, requiring intervention from medical staff. if the device were to fail, the surgical attendants, anaesthetist or doctor would see an over -distension of the pneumoperitoneum or difficulty in patient breathing. the manufacturer has received one adverse event report overseas where the device caused an overpressure situation.
  • Action
    Conmed is advising users to immediately check their facility for the affected unit(s) and to contact Conmed, who will in turn organise collection of the affected unit and return of the corrected unit. If necessary, Conmed will provide a loaner device whilst the product correction is undertaken.

Device

Conmed GS2000 - 50L Abdominal Insufflator(provides CO2 gas distension of surgical cavities via an...

Manufacturer

ConMed Linvatec Australia Pty Ltd