FDA Safety Alert: Updated Information for Healthcare Providers Regarding Duodenoscopes

The FDA has received inquiries from healthcare providers about whether they should cancel ERCP procedures, based on the fact that one specific model duodenoscope manufactured by Olympus (the ucm349567TJF-Q180V) does not currently have a 510(k) clearance.

On March 4, 2015 the FDA issued an updated statement emphasizing that the FDA is not recommending that healthcare providers cancel ERCP procedures for their patients who need them.  The FDA’s analysis indicates that the reported duodenoscope-associated infections have occurred in patients who have had procedures with duodenoscopes from all three manufacturers. At this time, FDA has no evidence that the lack of a 510(k) clearance was associated with the infections.

 Read Full Updated FDA Guidance