Olympus issued a device corrective action for its bronchoscopes used with laser therapy, argon plasma coagulation, or high-frequency cauterization equipment within the tracheobronchial tree, the FDA announced.
In 2023, the company had issued a voluntary field corrective action for 19 BF series laser-compatible bronchoscopes sold in the U.S. due to endobronchial combustion occurring when used during therapeutic procedures in combination with laser therapy equipment or argon plasma coagulation. Serious patient injury and one death were reported.
Later that year, the FDA announced an unrelated class I recall for 15 Olympus BF series bronchofiberscopes and bronchovideoscopes compatible with high-frequency therapy equipment due to risk of burns or fire in patients’ airways during therapeutic procedures. Four nonfatal injuries had been reported in relation to the problem since 2001.
Despite those actions, Olympus said it received reports of four additional incidents since 2023 involving serious injury, including one in the U.S.
The new voluntary global corrective action supersedes the 2023 one, clarifying use to further reduce the risk of combustion.
“If endobronchial combustion occurs, patients may suffer critical internal burns to the airway or lungs that may result in a requirement for additional medical intervention, prolonged procedure, extended hospitalization or ICU care, and death,” the company cautioned. “Combustion can also result in damage to or breakage of device components that may injure or remain unintendedly in the patient and/or may require retrieval or surgical removal.”
Olympus said its investigations of clinical conditions identified a risk of endobronchial combustion if laser therapy, argon plasma coagulation, or high-frequency cauterization are performed while supplying more than 40% oxygen and when the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.
It issued additional instructions to reduce the risk of combustion with these devices by ensuring the following are maintained:
- Separation of more than 4 cm between the endoscope and the endotracheal tube
- Oxygen levels below 40%
- Energy output less than 40 watts
- No excessive energy applied to one spot
- Use of suction to evacuate smoke
- Olympus had notified customers about the updates in instructions for use in a September letter and asked that all personnel be thoroughly aware of those updates when using its bronchoscopes.
The company has faced other safety and quality actions in recent years, including three warning letters in 2022 and 2023 due to what FDA had called “extensive and ongoing efforts with Olympus to address compliance issues related to the reprocessing of endoscopes.” Issues cited included failure to evaluate user reports of adverse events and to report those events to the FDA, as well as failure to verify and validate that its corrective actions were effective.
“Olympus’ continued failure to meet FDA requirements demonstrates a troubling disregard for patient safety,” said Jeff Shuren, MD, then-director of the FDA’s Center for Devices and Radiological Health, at the time.
Earlier this year, the FDA stopped certain Olympus bronchoscope models and other devices from entering the U.S. due to quality and compliance concerns.