Ultrasound Bronchoscope
FDA adverse event reports and recall history for ultrasound bronchoscope (product code PSV), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 5,860
- Deaths
- 7
- Injuries
- 378
- Malfunctions
- 5,475
Reports per year
Source: FDA adverse event reports by year received, 2016–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2023-11-17Open, ClassifiedUnder Investigation by firm
Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures within the airways, trancheobronchial tree, esophagus and surrounding organs Model Numbers: BF-UC180F, BF-UC190F.
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
- 2023-08-31Open, ClassifiedLabeling Change Control
Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F.
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
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