Events

Recall of PneumoSure XL High Flow Insufflator (Used to create a cavity by insufflating CO2 during diagnostics and/or therapeutic laparoscopy)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Stryker 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-00392-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00392-1
  • 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
    An issue has been identified that when the affected device is operating with a flow setting of 18l/min or greater and connected to a house gas inlet source, within seconds of insufflating the flow rate would drop to 0l/min and the red “check gas supply” symbol would appear on the display, immediately suspending insufflation.The failure produced by the defective product is the red “check gas supply” error on the display that occurs when the insufflator has a flow setting of 18l/min or greater. during a procedure, this would result in pressure decrease in the abdomen. unclear image due to poor abdominal distention is the hazardous situation associated with low gas pressure during a procedure.
  • Action
    Stryker is advising users to inspect stocks and quarantine any affected units. A Stryker representative will contact the affected customers to arrange for the removal and replacement of the affected units. This action has been closed-out on 02/02/2017.

Device

PneumoSure XL High Flow Insufflator (Used to create a cavity by insufflating CO2 during diagnosti...
  • Model / Serial
    PneumoSure XL High Flow Insufflator (Used to create a cavity by insufflating CO2 during diagnostics and/or therapeutic laparoscopy)Catalogue Numbers: 0620040610, 0620040611, 0620040600Multiple Lot Numbers affectedARTG Number: 139712
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA