Olympus Bronchoscopes Recall Considered Class I by FDA

Olympus Corporation of the America’s recall of 17,691 bronchofiberscopes and bronchovideoscopes due to burn and fire hazards has been identified as a Class I recall.

The bronchofiberscopes and brochovideoscopes are tubular devices that work with such accessories as cameras and lights to examine or treat a person’s airway. There is a risk of combustion if high-frequency cauterization is performed while supplying oxygen or the electrode section of an electrosurgical accessory is too close to the end of the endoscope.

There have been 192 complaints, including four injuries, but there have been no reported deaths. The FDA noted that the recall is a correction, not a product removal.

Read the FDA recall announcement here.

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