The US Food and Drug Administration (FDA) has recalled a series of Olympus bronchofiberscopes and bronchovideoscopes that could lead to a risk of burns and fire. The recall affects devices distributed between January 1, 2001, and September 11, 2023. Use of the devices may cause serious adverse events to patients and to clinicians, and healthcare workers using the devices may be affected in the event of combustion. Olympus is undergoing a formal CAPA (Corrective Action Preventative Action) process to investigate the root cause and potential contributing factors. The company has also asked facilities that have purchased any of the affected bronchoscopes to ensure that all personnel are “completely knowledgeable and thoroughly aware” of the warnings in the operations manual.
Source link
Olympus Issues Recall Correction for Bronchoscopes
