MedTech Dive January 3, 2025
Susan Kelly

Olympus advised providers to stop using an endoscope accessory due to an infection risk linked to 120 injuries and one death.

In the final days of 2024, the Food and Drug Administration notified the public of safety issues involving medical devices from Olympus, Trokamed, Nuwellis and Baxter. The early alert notices are part of an FDA pilot program launched in November designed to more quickly inform the public of potential high-risk device issues.

Olympus endoscope infection risk tied to 120 injuries

Olympus recommended healthcare providers stop using an endoscope accessory due to an infection risk linked to reports of 120 injuries and one death, according to a Dec. 23 early alert from the FDA.

The injury reports followed procedures in...

Today's Sponsors

Venturous
ZeOmega

Today's Sponsor

Venturous

 
Topics: FDA, Govt Agencies, Healthcare System, Medical Devices, Safety
AI Model FDA-Cleared to Triage 14 Conditions
The Promise And Perils Of FDA’s New ‘Plausible Mechanism’ Pathway (Part 2)
FDA Updates Two Digital Health Final Guidance Documents
FDA in Flux — January 2026 Newsletter
The Promise And Perils Of FDA’s New ‘Plausible Mechanism’ Pathway (Part 1)

Share Article