The FDA has issued an alert regarding automated endoscope reprocessors, as well as ureterorenoscopes, bronchoscopes and laparoscopes, manufactured by Olympus in Japan and has banned future shipments of these devices from entering the United States.

“Despite extensive and ongoing efforts to address compliance issues, FDA continues to have concerns related to outstanding Quality System regulation violations by Olympus,” according to the FDA alert, which the agency said followed warnings that “certain facilities were not in compliance with current good manufacturing practice … and various reporting requirements.” 

A table of affected devices and Unique Device Identifiers was included in the alert, which the FDA said does not apply to related devices such as replacement parts, connectors or single-use items used with the devices cited in the alert.

The FDA said those already using devices affected by the alert “may continue using these devices if you are not experiencing any problems” but advised staff to follow the instructions for use and refrain from using any device that is damaged or fails a leak test.

Procedures should not be canceled or delayed without a discussion with patients on the “benefits and risks associated with procedures involving these devices,” according to the release. “The FDA 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.” 

—GEN Staff