Olympus recalled 395 EVIS EXERA II bronchoscopes after updates revealed safety concerns. The bronchoscope's instructions for use with laser and coagulation equipment lacked clarity, posing high risks during procedures. Patients and healthcare providers must stop using this device and follow recall instructions immediately.
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions
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The Olympus BF-Q180-AC bronchoscope is a medical device used for visual examination and therapy within the bronchial tubes. Medical professionals commonly use it to assist patients with respiratory issues during procedures.
The latest updates to the use instructions may lead to improper use with laser or coagulation therapy equipment, resulting in complications that could endanger patient safety.
This recall is not part of a broader industry pattern.
The recall requires immediate action to cease use, affecting both healthcare providers and patients relying on its application in procedures.
Model number and UDI are typically found on the device's labeling or packaging.
Expect response and instructions from Olympus Corporation within a couple of weeks after reporting the issue.
Keep copies of all communications regarding this recall, including emails and notes of phone calls.
Model No. BF-Q180-AC. UDI: 4953170340086. 395 units recalled in the US; 165 units distributed outside the US.
No injuries or incidents have been reported.
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