TJF-Q180V Duodenoscope FAQs
Does the TJF-Q180V have 510(k) clearance now? What is the 510(k) #?
The TJF-Q180V has recently received FDA marketing clearance under 510(k) #K143153.
The letter says this is a voluntary removal/corrective action. Am I required to send my TJF-Q180V in and have the elevator replaced?
Yes, you must return your TJF-Q180V so we can replace the forceps elevator mechanism in your TJF-Q180V, beginning in February 2016. At an appropriate time, the Olympus service department will contact you to schedule the return of your duodenoscope(s) to replace the mechanism.
What changes are made to the forceps elevator?
The forceps elevator replacement will result in minor changes to the dimensional tolerance of the forceps elevator mechanism and O-ring. These changes will not be apparent through visual inspection.
Should we stop using our TJF-Q180Vs immediately?
No. You can continue to use the TJF-Q180V duodenoscope before the forceps elevator mechanism is replaced. You should immediately begin following the revised reprocessing instructions in the new Reprocessing Manual.
How quickly should we return our scopes to Olympus for their elevator replacement?
Please do not return your units prior to notification from Olympus unless you have unrelated repair issues. Olympus will contact all affected customers to provide a service window in which customers can return their units for replacement service. You can continue to use the TJF-Q180V duodenoscope until the forceps elevator has been replaced. Due to availability of parts, customers who return units prior to Olympus notification may not receive the replacement service nor prioritized turnaround.
Can I still use the same chemical in my non-Olympus AER?
For all automated endoscope reprocessors (AERs), Olympus recommends that you contact the manufacturer of your AER for further guidance and clarification on compatible chemistries.
How is the new reprocessing process different?
The new TJF-Q180V Reprocessing Manual features changes including:
- Precleaning and manual cleaning are now required even when using an Automated Endoscope Reprocessor (AER)
- The new TJF-Q180V Reprocessing Manual has updated parameters for ethylene oxide gas sterilization cycles
- Changes to the leakage test by extending the observation for bubbles through the instruction to, “Observe for approximately 30 seconds while deflecting the bending section of the endoscope by turning the endoscope's UP/DOWN and RIGHT/LEFT angulation control knobs to confirm that there is no location on the endoscope from which a continuous series of air bubbles emerges. Then observe for additional 30 seconds while raising and lowering the forceps elevator by moving the endoscope's elevator control lever to confirm that there is no location around the forceps elevator from which a continuous series of air bubbles emerges during the 30 seconds.”
This is not an exhaustive list of changes. It is important that you review the new TJF-Q180V duodenoscope Reprocessing Manual in detail. The inside cover page lists all changes in the new Reprocessing Manual.
Can I reprocess my scope in any AER?
The TJF-Q180V can be reprocessed in the Olympus OER-Pro. For all other automated endoscope reprocessors (AERs), Olympus recommends that you contact the manufacturer of your AER for further guidance and clarification on compatibility.
Can we still use our TJF-160VF & TJF-160F?
Yes. The TJF-160VF and TJF-160F duodenoscopes are unaffected by this action.
How long will it take you to contact me?
Olympus will contact facilities beginning in February. Olympus expects to complete all forceps elevator mechanism replacements by August 2016.
Can I get a loaner while you have my scope?
Olympus will contact customers to schedule the timeframe for this replacement service. Olympus is anticipating a 4 day turnaround time for replacement service including shipping. Olympus is actively increasing loaner pools to support urgent requests and loaners may be provided as available.