Olympus Issues Voluntary Labeling Update for Bronchoscopes Used with Laser Therapy Equipment
CENTER VALLEY, Pa. (July 3, 2023) – Olympus Corporation has announced a voluntary field corrective action to address complaints of endobronchial combustion occurring when laser-compatible bronchoscopes are used during therapeutic procedures in combination with laser therapy equipment or argon plasma coagulation (APC).
Olympus assessed the issue after receiving complaints of adverse events involving serious patient injury, and one death, and determined that updated labeling was needed to specify laser compatibility, warn about the risks that can result from incompatible laser use, and reinforce existing laser use warnings. This is not a removal action. Although Olympus received one complaint of endobronchial combustion with APC, the cause of the combustion event could not be determined, and Olympus is not making labeling updates to the use of APC. Patient and healthcare provider safety, and mitigating any potential risks are our top priorities.
Olympus bronchoscopes are intended for use in endoscopic diagnosis and treatment within the airways and the tracheobronchial tree. A total of 32 BF series endoscope models are globally included in this action. Nineteen of those models were distributed in the U.S. The U.S. Food and Drug Administration (FDA) and other regulatory bodies were notified of this action.
Olympus notified customers in the U.S. by letter on June 8, 2023, requesting that health care personnel treating patients using an Olympus bronchofiberscope or bronchovideoscope carefully read the full Medical Device Corrective Action and addendum detailing compatible laser types and ensure all personnel are completely knowledgeable and thoroughly aware that Olympus laser compatible bronchoscopes are compatible only with Nd: YAG laser or 810 nm diode lasers. Olympus has not evaluated any other lasers for compatibility with the indicated bronchoscope models.
Additionally, Olympus is reminding users to pay careful attention to warnings in the Operation Manual on laser cauterization with Olympus bronchoscopes. Olympus Operation Manuals warn not to perform laser cauterization while supplying oxygen. This may result in combustion during cauterization. In addition, to avoid patient injury (burns, bleeding, and perforation) or damage to the device, never emit laser radiation from an approved laser before confirming that an appropriate distance between the target and endoscope’s distal end with the tip of the laser probe is in the correct position in the endoscopic image.
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch program online: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda
For information or to report a problem, please contact the Olympus Technical Assistance Center at 800-848-9024, Option 1 or email email@example.com.