In an update on October 20, the FDA notified healthcare providers about an expanded import alert for certain medical devices that were manufactured in Japan by Olympus Medical Systems Corporation and its subsidiaries. The FDA explained:
“Despite extensive and ongoing efforts to address compliance issues, the FDA continues to have concerns related to outstanding Quality System regulation violations by Olympus.”
Import Alert 89-04 prevents shipments of the devices from entering the United States. The devices listed in the notice will be refused entry for failing to meet Quality System regulation requirements.
The update adds certain enteroscopes and ingestible telemetric gastrointestinal capsule imaging systems to the import alert that were manufactured at Olympus facilities in Japan.
The notice expands a June 2025 FDA letter that covered other types of scopes.
The import alert now covers specific models of the following medical devices:
- Ureterorenoscopes, which are used to perform various diagnostic and therapeutic procedures within the urinary tract,
- Bronchoscopes, which are used to perform various diagnostic and therapeutic procedures in the respiratory tract,
- Laparoscopes, which are used to perform various diagnostic and therapeutic procedures in the abdomen and pelvis,
- Automated endoscope reprocessors, which are used to reprocess various endoscopes,
- Ingestible telemetric gastrointestinal capsule imaging systems, which are used for visualization of the small bowel mucosa, and
- Enteroscopes, which are used to provide visualization and perform procedures within the small intestine.
The FDA’s list of affected models includes the Endocapsule Small Intestinal Capsule Endoscope Set (MAJ-2027), Evis Exera II Small Intestinal Videoscope (SIF-Q180), Endoeye Flex Deflectable Videoscope (LTF-S190-10), Bronchovideoscope (BF-1TH1100), and Bronchovideoscope (BF-H1100).
No injuries were reported, and for devices already in use, the FDA said healthcare providers may continue to use them if they are not experiencing any problems.
Health care providers can report adverse events or suspected adverse events through the FDA’s MedWatch program.
Patients who underwent procedures involving these devices may have legal options. A product liability attorney can advise you on your rights if you experienced complications from a scope procedure, such as infections transmitted on contaminated scopes.