Olympus Medical Systems Corporation (OMSC) and in consultation with the Therapeutic Goods Administration (TGA) is issuing a recall for product correction for the TJF-Q180V duodenoscope. The nature of this product correction is to issue revised manual cleaning and high level disinfection procedures.

You 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 highlighted below:

• 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

The following items have been sent to your Endoscopy Unit pertaining to this recall for product correction. If your facility has not received these items within five working days of this notice please advise Olympus customer service

• 1 x Box (50 pieces) Single use soft brush — Reference No. MAJ-1888
• 1 x Updated TJF-Q180V Reprocessing Manual — Reference No. RC2409

Olympus requires you to take the following action:

1. Remove and dispose of any existing TJF-Q180V reprocessing manuals and cleaning quick
reference guides
2. Implement the new reprocessing procedures for the TJF-Q180V
3. Ensure that all personnel involved in the reprocessing are knowledgeable and thoroughly
trained on the new reprocessing procedures
4. Contact Olympus on 1300 132 992 if you feel your staff could benefit from further training in the new reprocessing procedures, email education@olympus.com.au or speak to your local Sales Specialist
5. Please complete the relevant section(s) of the attached reply form, Appendix A and fax to 03 9562 6438 or reply via email to QARA@olympus.com.au regardless of whether you have any affected inventory at your facility

If you have distributed/transferred these products from your facility to another, please forward this recall notice and also notify Olympus so that we can follow up with that facility directly OMSC and Olympus apologise for any inconvenience this may cause and appreciate your cooperation in addressing this situation

If you have any questions regarding this product recall, please contact myself on 0467 555 676 or by email at Michael.McKenzieOlvmpus.com.au