Olympus Corporation has announced a voluntary corrective action involving bronchoscopes used in conjunction with certain high-risk therapeutic procedures. This update focuses on revised labeling instructions to enhance safety during procedures employing laser therapy, argon plasma coagulation, or high-frequency cauterization equipment. Regulatory, clinical, and quality professionals are strongly urged to review and adhere to the updated guidelines.
What changed in the labeling update?
As of October 31, 2025, Olympus issued revised instructions for bronchoscopes to address risks associated with specific therapeutic procedures, including endobronchial combustion. This follows a prior communication released in 2023 after adverse events were reported, including one fatality.
Since the 2023 Field Corrective Action, Olympus has conducted further investigations into clinical conditions during therapy, leading to the identification of additional labeling enhancements. Newly reported incidents include four cases of serious injury, with one occurring in the United States.
Updated guidelines: preventing combustion risks
Olympus now urges healthcare providers to adopt the following precautions to mitigate risks of combustion:
- Ensure a physical separation of at least 4 cm between the bronchoscope and the endotracheal tube.
- Maintain oxygen levels below 40% during the procedure.
- Limit energy output from devices to less than 40 watts.
- Avoid prolonged application of energy to a single spot.
- Utilize suction to effectively evacuate smoke from the procedure site.
These measures aim to reduce the potential for endobronchial combustion, which tends to occur when elevated oxygen levels are combined with proximity between the electrosurgical accessory and the scope’s distal end. This type of event may result in severe airway or lung burns, extended hospitalization, surgical retrieval of debris or damaged device components, and in extreme cases, death.
What should healthcare teams do?
Healthcare facilities using Olympus bronchoscopes coupled with laser therapy, argon plasma coagulation, or cauterization devices must ensure staff are thoroughly informed of the updated labeling instructions. Olympus directly notified customers via a letter in September 2025. Teams involved in therapeutic procedures within the tracheobronchial tree should immediately review and implement the revised guidelines to prioritize patient safety.
If adverse events or quality concerns arise during bronchoscope usage, healthcare professionals are advised to report these via the FDA’s MedWatch program or directly to Olympus.
Why it matters
This development underscores the importance of consistent vigilance in healthcare device use. As medical technology evolves, ongoing assessments by manufacturers help mitigate risks and safeguard patient health. Prompt adaptation to updated labeling and compliance instructions can prevent potentially catastrophic events during critical procedures.
Disclaimer
The information provided herein serves as an informative summary for healthcare and regulatory professionals. It is not legal or clinical advice. Always consult primary sources and device-specific instructions directly from the manufacturer.
Mandatory FDA Information
For full information about the FDA announcement, see the link below.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/olympus-issues-voluntary-labeling-update-bronchoscopes-used-laser-therapy-equipment