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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-00475-1
Product Name/Description	TJF-Q180V Duodenoscope ARTG Number 210858
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	3/06/2015
Responsible Entity	Olympus Australia Pty Ltd
Reason/Issue	Olympus Australia is issuing revised manual cleaning and high level disinfection procedures for the TJF-Q180V duodenoscope. Users are not required to return any devices to Olympus. Further to Olympus’ Safety Alert notification issued in March 2015, the manufacturer has since issued new reprocessing procedures applicable to the TJF-Q180V duodenoscope. Key changes in the new reprocessing procedures are:- - Inclusion of a new single use brush (MAJ-1888), for cleaning around the forceps elevator - Increase the number of raising/lowering of the forceps elevator and flushing of the elevator recess during pre-cleaning and manual cleaning. Ancillary cleaning items (Single use soft brushes and a new reprocessing Manual) have been sent to the relevant Endoscopy Units pertaining to this recall for product correction.
Recall Action	Recall for Product Correction
Recall Action Instructions	Users are asked to implement the new reprocessing procedures for the TJF-Q180V and to ensure that all personnel involved in the reprocessing are knowledgeable and thoroughly trained on the new procedures. This action has been closed-out on 13/10/2016.
Contact Information	03 9265 5435 Olympus