Service Announcements

Olympus provides you with the latest updates regarding the TJF-Q180V duodenoscope. This information addresses our customers in Europe, Middle East and Africa.

For specific questions regarding the Olympus Americas markets, please visit

http://medical.olympusamerica.com/duodenoscope

Please note that this update only refers to TJF-Q180V duodenoscopes manufactured prior to January 2016. Other duodenoscope models and TJF-Q180V duodenscopes delivered after March 2016 are unaffected by this corrective action.

Please note that you can continue to use your existing TJF-Q180V until contacted by Olympus to return it for repair.

As previously communicated, Olympus has now started to contact customers throughout the EMEA region to inform them about an urgent medical device corrective action involving TJF-Q180V duodenoscopes manufactured prior to January 2016.

Olympus is committed to ensuring maximum safety when using our products and sincerely regrets any inconvenience caused by the implementation of these measures. This webpage provides you with additional information about the corrective action for the TJF-Q180V, which is being conducted in two steps.

STEP 1: EXCHANGE OF OPERATING AND REPROCESSING MANUALS

In a first step, Olympus is issuing updated versions of the TJF-Q180V operating manual and reprocessing manual. Customers are currently being supplied with new operating and reprocessing manuals via post. We ask that customers immediately implement the new instructions upon receipt of the manuals.

The updated operating manual can be identified via the version number "RC2609_02" and includes additional visual inspections that must be conducted before and after patient procedures. In addition, a new annual inspection of the forceps elevator mechanism by Olympus service personnel is described. Both measures are being implemented to further reduce the risk of distal tip damage remaining unidentified during routine use of the endoscope, which can be a source of cross-infection risk.

The updated reprocessing manual requires users of Automated Endoscope Reprocessing (AER) systems to conduct the entire pre-cleaning and manual cleaning process as described in the reprocessing manual of the TJF-Q180V. This is intended as an additional safety measure to ensure that the endoscope is adequately cleaned prior to automated reprocessing. The updated reprocessing manual can be identified by the version number RC2603_02 on the rear page of the manual.

The measures described above represent additional safeguards to the reprocessing instructions issued in May 2015 which were previously validated and shown to deliver effective hygienic reprocessing of the TJF-Q180V when meticulously followed.

Summary of actions:

• Olympus is distributing local language operating and reprocessing manuals to all users
• Customers are asked to immediately implement the new manuals upon receipt

STEP 2: UPDATE OF ELEVATOR MECHANISM DESIGN TOLERANCES AND IMPLEMENTATION OF ANNUAL INSPECTION PROCESS

In an effort to further reduce the risk of fluid ingress into the internal mechanisms of the endoscope over time, Olympus has implemented a new forceps elevator mechanism design with updated production tolerances, especially related to the O-Ring design. These changes are not visible to the human eye. All TJF-Q180V endoscopes delivered from March 2016 onwards incorporate this new design and can be identified by the third digit of their serial number which contains the digit "1".

Starting in June 2016 and continuing for a period of 12 months, Olympus will successively contact users of existing TJF-Q180V endoscopes and arrange for their endoscopes to be collected for modification. Olympus will exchange the forceps elevator mechanism free-of-charge for the updated design version, which will take around 10 days.

The exchange of the elevator wire mechanism will be provided at our regional repair centres. In the unlikely event that we identify further repair need, we will contact customers before conducting any additional repair.

Olympus will successively contact customers and you do not need to proactively return your TJF-Q180V duodenoscope to us. Customers can continue to use existing design TJF-Q180V until contacted by Olympus, as the hygienic efficacy of the previous design model has been validated.

Summary of actions:

• Olympus will successively contact TJF-Q180V users over the next 12 months and ask them to return their endoscope for free-of-charge repair
• Users can continue to use their existing TJF-Q180V endoscope until contacted by Olympus

FURTHER OUTLOOK - ANNUAL INSPECTION PROCESS

As mentioned above, the updated instruction manual describes the necessity for an annual inspection of the TJF-Q180V by Olympus service personnel. The first inspection will become necessary 12 months after purchase of a new TJF-Q180V endoscope, or 12 months after the exchange of the elevator forceps mechanism as described above.

Olympus is currently defining the process for this annual inspection and will inform customers shortly about the exact setup, which is planned to commence in Summer 2017.

WHO CAN I CONTACT SHOULD I REQUIRE FURTHER INFORMATION?

Should you have any questions or require support, please contact your local Olympus representative who will be happy to provide further assistance. In addition, you can contact Olympus using the form below. This webpage will also be updated on regular intervals to keep you informed about the latest status. Olympus once again apologises for any inconvenience caused by the implementation of these additional measures.