Dive Brief:
- Olympus said last week that it has issued a corrective action to further clarify the safe and effective use of bronchoscopes in certain scenarios.
- The updated instructions for use reflect the outcomes of investigations that Olympus has carried out since 2023, when it issued its initial corrective action.
- Olympus has received reports of four additional incidents involving serious injury, including one death from the U.S., since 2023.
Dive Insight:
The update covers the use of Olympus bronchoscopes with laser therapy, argon plasma coagulation or high-frequency cauterization equipment in procedures targeting the branching tree of airways that get air into the lungs.
In 2023, Olympus responded to reports that endobronchial combustion had caused burns to airways and lungs. Yet Olympus continued to receive reports of serious injuries.
Olympus has provided new recommendations in response to the findings of additional assessments of the use of the devices. Users should keep the endoscope at least 4 cm from the endotracheal tube, have oxygen levels of less than 40% and energy output of less than 40 watts, avoid applying excessive energy to one spot and use suction to evacuate smoke.
Failure to follow the instructions creates a risk of endobronchial combustion. The resulting burns to the airways or lungs can require additional medical intervention, prolong procedures and extend hospitalizations. There is also a risk of death. Olympus added that combustion can damage devices “that may injure or remain unintendedly in the patient and/or may require retrieval or surgical removal.”
The company told customers about the updated instructions for use in September. Olympus followed up last week with a press release conveying the same advice as the urgent medical device correction letter.
Olympus’ notices about the bronchoscopes are part of a wider set of safety and quality actions. The FDA hit the company with three warning letters in late 2022 and 2023 after inspectors found issues including a “troubling disregard for patient safety.” Earlier this year, the FDA stopped certain Olympus devices from entering the U.S. Olympus is working to address the issues under recently appointed CEO Bob White.
