A company-initiated recall of nearly 68,000 Olympus bronchoscopes is now deemed class I by the FDA because of the risk of endobronchial combustion, which could cause serious injuries or death.

Olympus said in its Nov. 9 notice to customers that the company had received complaints of adverse events that occurred “during therapeutic procedures involving use of high-frequency therapy equipment in an oxygenated environment.”

The FDA says the reason for the recall is the “risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.”

The company is not removing the device from the market but is reminding clinicians to “carefully read the full Medical Device Corrective Action and ensure all personnel are completely knowledgeable and thoroughly aware of the warnings for use with compatible high-frequency therapy equipment, such as electrosurgical generators.”

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