Olympus Wins FDA Clearance for Modified Duodenoscope
The FDA has blessed Olympus with clearance for its TJF-Q180V duodenoscope with modifications to the device’s design and labeling.
Its new design of the elevator channel sealing mechanism looks to create a tighter seal and reduce the potential for leakage of fluids and tissue into the closed elevator channel.
The modifications – which aim to help reduce the risk of bacterial infections – come amid several reports of duodenoscopes being linked to the transmission of antibiotic-resistant infections.
Olympus says it will implement a corrective action in the U.S. for currently used TJF-Q180V duodenoscopes. The action involves replacing the forceps elevator mechanism with a new forceps elevator design. — Michael Cipriano