#United States #Medical Devices #Center Valley #laser therapy #Olympus Bronchoscopes

Olympus Enhances Safety Guidelines for Bronchoscopes

Olympus Corporation has recently announced a voluntary, global corrective action regarding medical devices, specifically bronchoscopes used in conjunction with laser therapy, argon plasma coagulation, and high-frequency cauterization equipment. This action aims to clarify the safe and effective use of these devices during therapeutic procedures in the tracheobronchial tree.

This update follows an earlier communication made in 2023, which addressed concerns surrounding adverse events involving endobronchial combustion with Olympus bronchoscopes, an incident linked to one fatality. After further evaluation and assessments following the 2023 advisory, Olympus became aware of additional reports detailing serious injuries, including four new incidents, one of which occurred in the U.S. These findings prompted Olympus to revise the guidelines to improve patient safety significantly.

The company informed customers of critical updates via a letter distributed in September 2025. Users are urged to educate their personnel about these changes to ensure adherence to the new instructions when operating bronchoscopes.

Among the newly implemented guidelines, Olympus emphasizes that:

• - A minimum distance of greater than 4 centimeters must be maintained between the endoscope and the endotracheal tube during procedures.
• - The oxygen flow should remain below 40% to mitigate combustion risks.
• - The energy output must be restricted to under 40 watts.
• - Operators should avoid applying excessive energy to a single location and utilize suction to effectively clear smoke generated during these procedures.

If the protocol is not strictly followed, there is an elevated risk of endobronchial combustion, particularly when using laser therapy or other related techniques, especially with elevated oxygen levels or when the electrode is too close to the endoscope’s distal end. Such events can result in life-threatening internal burns to the airway or lungs and may necessitate extensive medical interventions, prolonged hospital stays, or even ICU care. In severe cases, loss of life could occur.

In instances of combustion, damaged device components can lead to complications, such as piece breakage that remains inside the patient, requiring surgical retrieval.

To ensure that all potential adverse reactions or quality issues with these medical devices are appropriately reported, Olympus encourages healthcare professionals to consult the relevant instructions for use. Additionally, any serious problems or concerns regarding the product can be reported through the FDA's MedWatch program.

If healthcare personnel encounter issues or need assistance with the devices, they can contact the Olympus Technical Assistance Center via phone at 1-800-848-9024 or through email for support.

In conclusion, while Olympus strives to enhance its devices' safety systems, effective communication and adherence to updated usage guidelines are vital in ensuring patient safety during complex therapeutic procedures. The company remains committed to supporting its users with clearer instructions and safety protocols to mitigate potential hazards associated with the use of bronchoscopes in conjunction with advanced therapeutic equipment.