Olympus Pulmonary Endoscopes

Olympus has received three complaints, including one that was associated with an injury, that upon trying to use an Olympus pulmonary endoscope model with an endotracheal tube, the tip became lodged (entrapped) inside the endotracheal tube connector. As a result of the complaint investigation, it was determined that the scope (bending section) was too large for the endotracheal tube connector. Selection of an endotracheal tube where the size is incompatible with the Olympus airway mobilescope can result in delayed procedures, foreign body obstruction, failure to ventilate the patient, hemorrhage, upper airway tract injury, esophageal perforation, and/or airway mobilescope damage.

In an effort to maximize patient safety and mitigate any potential risk to patient health, Olympus is providing the following information related to using an endotracheal tube:
• before inserting the airway mobilescope with an endotracheal tube into the patient, slide the tube along the entire length of the airway mobilescope insertion section to confirm that the insertion section of the airway mobilescope can be inserted smoothly into the endotracheal tube. If it cannot be inserted smoothly, the covering material of the bending section of the airway mobilescope or the external surface of the insertion section may be damaged. When using a lubricant, make the above confirmation before applying the lubricant.

In the event the endotracheal tube cannot slide smoothly over the insertion section of the airway mobilescope, select another size tube, or inspect scope for damage.

Olympus  is undertaking this action to provide an IFU addendum which specify the correct maximum scope diameter information.

Recall start date: July 28, 2023