The FDA is alerting health care providers about import alerts for certain medical devices manufactured in Japan by Olympus and its subsidiaries.
The agency said that despite extensive and ongoing efforts to address compliance issues, it continues to have concerns related to outstanding Quality System regulation violations by Olympus. Therefore, it has issued import alerts to prevent future shipments of certain devices from entering the United States, including specific models of:
- 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
The FDA said it has taken several actions related to quality system requirements and compliance concerns with Olympus. The agency said it is continuing to engage with Olympus to accelerate corrective actions related to ongoing violations and minimize risk to patients, and may take further action as appropriate.
