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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00498-1
Product Name/Description	Monopolar HF Resection Electrodes Model Number: A22201C Lot Numbers: 16123P03L001, 16139P03L001, 16144P03L001, 16173P03L001, 16174P03L001, 16210P03L001, P16X0001, P16X0002, P16Y0001 and P16Y0003 Model Number: WA22037C Lot Number: P16Y0001 ARTG Number: 218223
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	20/04/2017
Responsible Entity	Olympus Australia Pty Ltd
Reason/Issue	The manufacturer, Olympus Winter & Ibe has received an increased number of complaints regarding loop wires breaking at the distal end of the electrodes. Investigations have confirmed that loop wires can break during the intended use of the electrodes. As a result, a fragment may fall inside the patient and will need to be retrieved. Under certain circumstances, the retrieval could require additional surgical treatment. To date, no reports of adverse events or patient injuries have been received by Olympus.
Recall Action	Recall
Recall Action Instructions	Olympus is requesting users to inspect their inventory and quarantine the affected lots. Affected products are to be returned for replacement. This action has been closed-out on 26/03/2018.
Contact Information	02 9265 5591 - Olympus