Modified TJF-Q180V duodenoscope receives 510(k)approval for use in Endoscopic Retrograde Cholangiopancreatography (ERCP)- Olympus Medical

The FDA has cleared the Olympus TJF-Q180V duodenoscope with modifications to the device’s design and labeling intended to help reduce the risk of bacterial infections. Olympus will voluntarily recall its original model currently being used in healthcare facilities and make the needed repair as quickly as possible.

In March 2014, the FDA notified Olympus that they needed to submit a premarket notification, called a 510(k), for their 'closed' elevator channel model, which had never been cleared for marketing. In a letter sent to Olympus, the agency stated that design changes to this model from previous models, which resulted in a 'closed' rather than 'open' elevator channel, were significant and impacted the safe use of the device. The company subsequently submitted a 510(k) for the TJF-Q180V, and the FDA has now determined that the model with the newly designed mechanism is substantially equivalent to previously cleared duodenoscopes.

In addition, Olympus is initiating a voluntary recall of the original TJF-Q180V model from healthcare facilities to replace the elevator channel sealing mechanism at the tip of the scope with a new sealing mechanism; the new mechanism is designed to reduce the risk of fluid leakage into the elevator channel. The company estimates it will be able to correct the mechanism in the approximately 4,400 TJF-Q180V models currently used in healthcare facilities throughout the US by August 2016. While awaiting repair, health care facilities may continue to use the Olympus TJF-Q180V, but they should meticulously follow the manufacturer's reprocessing instructions.

Olympus plans to contact each facility that owns a TJF-Q180V duodenoscope and will provide instructions on returning the original TJF-Q180V for this replacement that Olympus will provide free of charge. Olympus estimates a four-day turnaround time to replace the elevator mechanism once it receives a duodenoscope from a healthcare facility.

Comment: Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. The FDA has been working with duodenoscope manufacturers as they modify and validate their reprocessing instructions to further enhance the safety margin of their devices and show with a high degree of assurance that their reprocessing instructions, when followed correctly, effectively clean and disinfect the duodenoscopes.