Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00392-1
Product Name/Description PneumoSure XL High Flow Insufflator (Used to create a cavity by insufflating CO2 during diagnostics and/or therapeutic laparoscopy)

Catalogue Numbers: 0620040610, 0620040611, 0620040600

Multiple Lot Numbers affected

ARTG Number: 139712
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 4/04/2016
Responsible Entity Stryker Australia Pty Ltd
Reason/Issue 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
Recall Action Recall
Recall Action Instructions 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.
Contact Information 02 9467 1175 - Stryker Australia