Mon Nov 03 2025

View source

Medical Devices

Reason for Recall

Potential for endobronchial combustion

Product Information:

Brand	Company	Product Description
Olympus	Olympus Corporation	Bronchofiberscopes and bronchovideoscopes

Company Announcement

CENTER VALLEY, Pa., (October 31, 2025) – Olympus Corporation has announced a voluntary, global medical device corrective action to provide further clarification on the safe and effective use of bronchoscopes with laser therapy, argon plasma coagulation or high-frequency cauterization equipment during therapeutic procedures within the tracheobronchial tree.

This corrective action supersedes the previous related communication in 2023 to address adverse event complaints of endobronchial combustion involving therapeutic instruments with Olympus bronchoscopes, which included one death.

Since the Field Corrective Action in 2023, Olympus conducted additional assessment on the use of bronchoscopes with laser therapy, argon plasma coagulation, and high-frequency cauterization equipment. Through these investigations of clinical conditions, Olympus determined that additional updates to the instructions for use are necessary. Since 2023, Olympus has received reports of four additional incidents involving serious injury, including one from the U.S.

Customers were notified of the instructions for use updates through a September 2025 letter and are asked to ensure all personnel are completely knowledgeable and thoroughly aware of the updates to the instructions for use contained in the customer letter when using the bronchoscopes.

Additional instructions to further reduce the risk of potential combustion associated with the use of laser therapy, argon plasma coagulation, or high-frequency cauterization equipment include specific recommendations: ensuring there is separation of >4cm between the endoscope and the endotracheal tube; oxygen levels of less than 40%; energy output of less than 40 watts; avoiding excessive energy applied to one spot; and the use of suction to evacuate smoke.

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.

Note: Olympus advises users to consult the respective instructions for use for devices that may be used with Olympus bronchoscopes.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch program online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda.

For information or to report a problem about the device, please contact the Olympus Technical Assistance Center at 1-800-848-9024, Option 1 or email complaints@olympus.com.

Published Documents:

Info not provided.

Mon Nov 03 2025

View source

Medical Devices

Reason for Recall

Potential for endobronchial combustion

Product Information:

Brand	Company	Product Description
Olympus	Olympus Corporation	Bronchofiberscopes and bronchovideoscopes

Company Announcement

CENTER VALLEY, Pa., (October 31, 2025) – Olympus Corporation has announced a voluntary, global medical device corrective action to provide further clarification on the safe and effective use of bronchoscopes with laser therapy, argon plasma coagulation or high-frequency cauterization equipment during therapeutic procedures within the tracheobronchial tree.

This corrective action supersedes the previous related communication in 2023 to address adverse event complaints of endobronchial combustion involving therapeutic instruments with Olympus bronchoscopes, which included one death.

Since the Field Corrective Action in 2023, Olympus conducted additional assessment on the use of bronchoscopes with laser therapy, argon plasma coagulation, and high-frequency cauterization equipment. Through these investigations of clinical conditions, Olympus determined that additional updates to the instructions for use are necessary. Since 2023, Olympus has received reports of four additional incidents involving serious injury, including one from the U.S.

Customers were notified of the instructions for use updates through a September 2025 letter and are asked to ensure all personnel are completely knowledgeable and thoroughly aware of the updates to the instructions for use contained in the customer letter when using the bronchoscopes.

Additional instructions to further reduce the risk of potential combustion associated with the use of laser therapy, argon plasma coagulation, or high-frequency cauterization equipment include specific recommendations: ensuring there is separation of >4cm between the endoscope and the endotracheal tube; oxygen levels of less than 40%; energy output of less than 40 watts; avoiding excessive energy applied to one spot; and the use of suction to evacuate smoke.

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.

Note: Olympus advises users to consult the respective instructions for use for devices that may be used with Olympus bronchoscopes.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch program online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda.

For information or to report a problem about the device, please contact the Olympus Technical Assistance Center at 1-800-848-9024, Option 1 or email complaints@olympus.com.

Published Documents:

Info not provided.

- views

- views

0 views

0 views

Mon Nov 03 2025

View source

0 views

Medical Devices

Reason for Recall

Potential for endobronchial combustion

Product Information:

Brand	Company	Product Description
Olympus	Olympus Corporation	Bronchofiberscopes and bronchovideoscopes

Company Announcement

CENTER VALLEY, Pa., (October 31, 2025) – Olympus Corporation has announced a voluntary, global medical device corrective action to provide further clarification on the safe and effective use of bronchoscopes with laser therapy, argon plasma coagulation or high-frequency cauterization equipment during therapeutic procedures within the tracheobronchial tree.

This corrective action supersedes the previous related communication in 2023 to address adverse event complaints of endobronchial combustion involving therapeutic instruments with Olympus bronchoscopes, which included one death.

Since the Field Corrective Action in 2023, Olympus conducted additional assessment on the use of bronchoscopes with laser therapy, argon plasma coagulation, and high-frequency cauterization equipment. Through these investigations of clinical conditions, Olympus determined that additional updates to the instructions for use are necessary. Since 2023, Olympus has received reports of four additional incidents involving serious injury, including one from the U.S.

Customers were notified of the instructions for use updates through a September 2025 letter and are asked to ensure all personnel are completely knowledgeable and thoroughly aware of the updates to the instructions for use contained in the customer letter when using the bronchoscopes.

Additional instructions to further reduce the risk of potential combustion associated with the use of laser therapy, argon plasma coagulation, or high-frequency cauterization equipment include specific recommendations: ensuring there is separation of >4cm between the endoscope and the endotracheal tube; oxygen levels of less than 40%; energy output of less than 40 watts; avoiding excessive energy applied to one spot; and the use of suction to evacuate smoke.

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.

Note: Olympus advises users to consult the respective instructions for use for devices that may be used with Olympus bronchoscopes.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch program online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda.

For information or to report a problem about the device, please contact the Olympus Technical Assistance Center at 1-800-848-9024, Option 1 or email complaints@olympus.com.

Published Documents:

Info not provided.