Olympus Corporation has announced an important voluntary labeling update for bronchoscopes used with laser therapy, argon plasma coagulation, and high-frequency cauterization equipment. The global corrective action aims to clarify safe usage to prevent incidents of endobronchial combustion during therapeutic procedures within the tracheobronchial tree. This update follows additional investigations into reported adverse events, including serious injuries and one death.
Key points:
- Voluntary corrective action announced globally on October 31, 2025.
- Safety instructions updated to address risks of endobronchial combustion.
- Four additional serious injury reports since 2023, including one from the U.S.
- Enhanced instructions for personnel handling Olympus bronchoscopes.
Below are navigation links to help you explore the full report:
- What are the updated safety guidelines?
- What risks are associated with endobronchial combustion?
- How can adverse reactions be reported?
What are the updated safety guidelines?
Olympus has issued new recommendations to minimize risks associated with laser bronchoscopes. These guidelines include:
- Ensure a separation of more than 4 cm between the endoscope and the endotracheal tube.
- Maintain oxygen levels below 40% during procedures.
- Use laser equipment with energy output under 40 watts.
- Avoid applying excessive energy in one spot.
- Utilize suction to evacuate smoke generated during procedures.
The updated instructions aim to mitigate risks associated with therapeutic interventions involving bronchoscopes, especially when using oxygen concentrations beyond 40%.
What risks are associated with endobronchial combustion?
The use of laser therapy, argon plasma coagulation, or electrosurgical equipment with bronchoscopes carries the potential for endobronchial combustion. This can lead to:
- Critical internal burns affecting the airway and lungs, potentially leading to ICU care or prolonged hospitalization.
- Complications such as device damage or unintended detachment of components in the patient.
- The need for device retrieval or surgical removal.
- In severe cases, death.
The adverse incidents underscore the importance of vigilance when using bronchoscopes alongside highly reactive equipment.
How can adverse reactions be reported?
Healthcare professionals who experience quality problems with Olympus bronchoscopes are advised to report these issues directly to the FDA through its MedWatch program. Reports can be submitted online via the FDA MedWatch page.
For assistance or additional details regarding Olympus bronchoscopes, users can contact the Olympus Technical Assistance Center at 1-800-848-9024 (Option 1) or via email at complaints@olympus.com.
FAQ
- Why did Olympus issue this update?
The update follows investigations into adverse events, including four serious injuries since the 2023 Field Corrective Action and one reported death. - Who is affected?
Healthcare professionals using Olympus bronchoscopes with laser therapy or related electrosurgical equipment. - What immediate actions should users take?
Personnel should familiarize themselves with the updated safety instructions and ensure safe practices are followed. - Where can I report a safety issue?
Issues can be reported to the FDA’s MedWatch program, or directly to Olympus via their helpline or email.
Conclusion
The voluntary labeling update by Olympus emphasizes patient safety and adherence to updated operating procedures for bronchoscopes used in therapeutic systems. Healthcare teams should review and incorporate these latest guidelines into standard practice to minimize safety risks.
Disclaimer
This article is for informational purposes only and does not constitute legal advice. Always consult regulatory guidance and product manuals for compliance.
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