The FDA is shutting the door to imports of certain endoscope hardware manufactured by Olympus, saying that a production site in Japan has failed to meet quality requirements.
The agency cautioned healthcare providers that future medical device shipments will be refused entry to the U.S., namely 58 specific models of laparoscopes, bronchoscopes, nasopharyngoscopes and ureteroscopes, as well as automated cleaners and reprocessing accessories.
“Despite extensive and ongoing efforts to address compliance issues, FDA continues to have concerns related to outstanding Quality System regulation violations by Olympus,” the agency said in its letter to providers.
The FDA said that health systems may continue to use any devices they may already have, as long as they are not experiencing any problems—for example, if hardware has failed a leak test, that could provide a route to contamination.
In addition, the import alert does not apply to products such as replacement parts, connectors and single-use consumables that are used alongside the affected scopes.
“The FDA does not recommend that procedures be canceled or delayed without discussion of the benefits and risks between the health care provider and patient,” the agency said.
The regulator said it has taken several actions related to quality system requirements and compliance concerns with Olympus and its Aizu subsidiary, with its sterile endoscope manufacturing facility located in Japan’s Fukushima prefecture, and that it will continue to work with the company to implement corrective actions.
The FDA previously sent a warning letter to Aizu Olympus Co., Ltd., in November 2022, citing a lack of written procedures and documentation for certain assembly and cleaning processes.
A few months later, the broader Olympus Medical Systems Corp. received a separate warning letter related to a Tokyo site that produces accessories for duodenoscopes and bronchoscopes—following complaints of cracked distal end caps, and some coming loose within a patient during a procedure.
During that period, the company also received a third missive from the FDA, saying it had failed to report device failures and malfunctions within an adequate timeframe. At that time, the agency’s leadership said that “Olympus’ continued failure to meet FDA requirements demonstrates a troubling disregard for patient safety.”
In late 2023, the FDA issued a Class I recall designation, its most serious, to cover more than 17,600 video bronchoscopes distributed across the U.S. since 2001.
No products were removed from the market or returned to the manufacturer at that time; Olympus said it had received four reports of fires sparking within patients’ lungs when the scopes were used alongside high-frequency cauterization equipment within a high-oxygen environment.