January 15, 2016 — Olympus Corp. has issued a recall for the TJF-Q180V duodenoscope to make design changes that should reduce the risk of infections.
The changes include a new sealing mechanism in the tip of the scope to prevent patient fluids from leaking inside. This should make the scopes easier to clean and reduce the risk of spreading antibiotic-resistant “superbug” infections among patients.
Olympus has been selling the scope without clearance from the FDA since 2010. The FDA has now approved the scope while Olympus recalls it to fix design flaws. Olympus said it did not believe a new approval application was necessary, despite significant design changes in TJF-Q180V compared to previous models.
The company tightened the seal around a complex “elevator” mechanism to prevent patient fluids from getting inside. The “closed” channel was supposed to lower the risk of infection compared to “open” channel scopes. The problem is that when fluids do leak inside, the closed channel is extremely difficult to sterilize. According to the FDA:
“Leakage into this channel could pose an infection risk to subsequent patients exposed to the contaminated device because the sealed area cannot be cleaned and disinfected between uses.”
According to a Senate report earlier this week, Olympus knew that design flaws could lead to infections in early 2012, but did not warn the FDA until February 2015. In the meantime, the scopes were linked to dozens of “superbug” outbreaks and at least 141 infections.