Olympus issues voluntary labeling update for bronchoscopes used with laser therapy equipment

Olympus Corporation 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, according to a November 3 notification from the US Food and Drug Administration.

The labeling update addressed a risk of endobronchial combustion if laser therapy, argon plasma coagulation, or high-frequency cauterization is performed while supplying oxygen in excess of 40%. A safety risk was also discussed when the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.

Endobronchial combustion can cause severe internal burns to the airway or lungs, potentially requiring ICU care or leading to death. This combustion can also result in device components becoming damaged or broken, which may require retrieval or surgical removal.

The FDA notification stated this labeling update for corrective action supersedes a previous related communication in 2023 to address adverse event complaints of endobronchial combustion involving therapeutic instruments with Olympus bronchoscopes, which included one death.

Customers were notified of the instructions for use updates and were asked to ensure all personnel are notified regarding updates to instructions for use. Additional instructions to reduce the risk of potential combustion associated with the use of laser therapy, argon plasma coagulation, or high-frequency cauterization equipment included specific recommendations, were also discussed in the notification. These include:

*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
*Use of suction to evacuate smoked