Olympus Issues Voluntary Label Update for Bronchoscopes Following Complaints

By Denny Jacob

Olympus Corp. on Monday said it issued a voluntary labeling update in response to complaints of endobronchial combustion for bronchoscopes used with laser therapy equipment.

The Japanese precision machineries and instruments maker said it assessed the issue after receiving complaints of adverse events involving serious patient injury as well as one death. The company said it determined that updated labeling was needed to specify laser compatibility, warn of risks from incompatible laser use and reinforce existing laser use warnings.

Olympus said a total of 32 BF series endoscope models are globally included in its action, 19 of which were distributed in the U.S. The company said the Food and Drug Administration and other regulatory bodies were notified of its action.

Olympus bronchoscopes are intended for use in endoscopic diagnosis and treatment within the airways and the tracheobronchial tree, the company said.

Write to Denny Jacob at denny.jacob@wsj.com

(END) Dow Jones Newswires

July 03, 2023 17:35 ET (21:35 GMT)

Copyright (c) 2023 Dow Jones & Company, Inc.