January 15, 2015 — Olympus Corp. will recall a duodenoscope to make repairs intended to reduce the risk of bacterial infections.
The Olympus TJF-Q180V scope has been on the market since 2010 without clearance from the FDA or proof the cleaning instructions actually worked. Adequate instructions were not approved until March 2015.
Olympus said it did not believe FDA approval was necessary, despite significantly changing the design from an “open” channel to a “closed” channel in the tip of the scope.
The closed channel has a tighter seal around the elevator mechanism. The seal was supposed to stop the leakage of patient fluids and tissue into the scope. Unfortunately, when leakage does occur, the closed channel is extremely difficult to clean.
Since the design changes, The TJF-Q180V has been blamed on several outbreaks of antibiotic-resistant infections. 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.”
The FDA has now approved the TJF-Q180V while Olympus simultaneously recalls it to replace the elevator channel sealing mechanism. The new seal is designed to reduce the risk of fluid leakage into the elevator channel. Olympus estimates it will be able to fix about 4,400 scopes by August 2016.
Olympus sells about 85% of the duodenoscopes used in the United States. They are used in over 500,000 procedures every year. Earlier this week, a Senate report blamed contaminated scopes on 25 outbreaks of antibiotic-resistant “superbugs.” Olympus allegedly knew about design flaws since early 2012, but failed to take action or warn regulators until February 2015. Their failure contributed to at least 141 infections, investigators said.