Bronchofiberscopes and bronchovideoscopes

  • Potential for endobronchial combustion
  • Company: Olympus Corporation
  • Medical Devices
  • FDA
  • October 31, 2025

Product details

  • Bronchofiberscopes and bronchovideoscopes

Company announcement

Olympus Corporation issued a voluntary global medical device corrective action regarding the use of bronchoscopes with laser therapy, argon plasma coagulation, or high-frequency cauterization equipment.

The update addresses the potential for endobronchial combustion during therapeutic procedures.

One death was reported in a previous communication in 2023. Since 2023, Olympus has received reports of four additional incidents involving serious injury, including one from the United States.

Customers were notified of the instructions for use updates through a September 2025 letter.

Risk:

There is a risk of endobronchial combustion if laser therapy, argon plasma coagulation, or high-frequency cauterization is performed while supplying oxygen in excess of 40% and/or the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope. 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. 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.

Impacted states: Nationwide

Contact

For more information, call (800) 848-9024 or email complaints@olympus.com.

View the original FDA notice

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