| Reason for the Action |
Olympus received notification of a fire-related incident involving the OER-PRO. After an extensive investigation, the root cause of this incident could not be conclusively determined. Out of an abundance of caution, Olympus is providing Warnings/Cautions reminders associated with all affected Olympus Endoscope Reprocessors.
Harms associated with a fire or thermal event may include user burns or respiratory difficulties. Thermal injuries sustained in facility reprocessing room fires could pose critical or life-threatening risks, particularly in environments where flammable gases, oxygen sources, or combustible materials may be present. Exposure to smoke or fumes emitted may result in respiratory difficulties with prolonged exposure. Additionally, this problem can cause operational disruptions, including delays or cancellations.
There were no patient or staff injuries that occurred during this incident. |