The FDA on Oct. 20 added five more Olympus device models to an import alert, including the company's Endocapsule small-intestine capsule endoscope set and a small-intestine videoscope. The agency cited outstanding quality system violations. The alert lets the FDA refuse future shipments at the border, but it does not order hospitals to pull devices already in use.
The newly listed models, according to the FDA letter to health care providers, are the Endocapsule Small Intestinal Capsule Endoscope Set (MAJ-2027), the Evis Exera II Small Intestinal Videoscope (SIF-Q180), the Endoeye Flex Deflectable Videoscope (LTF-S190-10) and two bronchovideoscopes (BF-1TH1100 and BF-H1100). The FDA said the update broadens the alert to cover devices made at locations in Japan.
