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Today, the U.S. Food and Drug Administration (FDA) issued a Letter to Health Care Providers about import alerts for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation (Olympus) and its subsidiaries. The FDA has issued import alerts to prevent future shipments of certain devices from entering the United States, including specific models of:
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Ureterorenoscopes, which are used to perform various diagnostic and therapeutic procedures within the urinary tract
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Bronchoscopes, which are used to perform various diagnostic and therapeutic procedures in the respiratory tract
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Laparoscopes, which are used to perform various diagnostic and therapeutic procedures in the abdomen and pelvis
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Automated endoscope reprocessors, which are used to reprocess various endoscopes
The Letter to Health Care Providers includes important information about these medical devices, including:
- Details on the devices subject to import alert
- Recommendations for health care providers
- Actions that the FDA has taken to address the ongoing quality system regulation violations by Olympus
- Instructions for reporting problems with a device
Questions?
If you have questions, contact the Division of Industry and Consumer Education.
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