AABIP Advocacy Statement

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AABIP Advocacy Committee Statement Regarding Olympus Biopsy Valves (download pdf) 

The AABIP Advocacy Committee is aware of the recent Olympus Field Safety Notice regarding MAJ-210 and MAJ-1218 single-use biopsy valves and the reported risk of rubber fragment detachment during bronchoscopy (see appended file). We recognize the potential for patient harm, including retained foreign bodies and procedural complications, and appreciate Olympus’ transparency in communicating these findings and ongoing investigation.

At this time, the notice does not call for product removal but emphasizes strict adherence to inspection protocols and proper technique when inserting and withdrawing endotherapy devices. We strongly encourage all interventional pulmonology teams to review this guidance, reinforce best practices with procedural staff, and maintain heightened vigilance during bronchoscopic procedures.

Patient safety remains our highest priority. We support continued reporting of any adverse events through institutional channels and regulatory systems, and we look forward to further updates as additional data and root cause analyses become available. AABIP remains committed to working collaboratively with clinicians, industry partners, and regulatory bodies to ensure safe and effective use of bronchoscopic technologies.

We encourage members to report any adverse events through appropriate institutional channels and to the FDA’s MedWatch program to support ongoing safety surveillance.

https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/medical-product-safety-information