A medical device used to diagnose and treat pancreatic and bile duct disease is getting attention from the U.S. Food and Drug Administration after pieces have fallen off and remained in patients’ bodies. Previously, the FDA had expressed concern about duodenoscopes because they can be difficult to clean and may spread bacteria such as E. coli from patient to patient. Duodenoscopes are flexible, lighted tubes with a camera that are threaded through the mouth down to the stomach and top of the small intestine (duodenum). However, when hospitals switched to disposable tips to cover the camera and reduce bacteria spread, this has now resulted in new problems. Those produced by Olympus Medical Systems have fallen off in patients’ mouths and stomachs, according to reports filed with the FDA. Some have sharp edges, which has led to internal bleeding in patients, according to the New York Times. The FDA has received about 160 complaints about the caps falling off. That “was above the expected numbers for that type of complaint,” according to Olympus’ own analysis. The FDA sent a warning letter to the company after an inspection at the Olympus plant in Tokyo late last year found that disposable parts made for duodenoscopes and suction valves for bronchoscopes, which are used to examine the lungs, were adulterated or defective. The agency has said the company’s responses… read on > read on >

















