Category: Adverse Event Reports

Guidance to Prevent Adverse Events, Including Mucosal Tissue Injuries, When Using Duodenoscopes with a Single-Use Endcap

Updated guidance is provided to reduce the risks of mucosal injuries and the endcap becoming detached and falling off inside the patient when using a duodenoscope with a single-use endcap.

Resistant Infections Linked to Gastroscopes — Is the Concern Sufficiently Recognized?

This article presents an FDA report filed in November — publicized now for the first time — that links gastroscopes to 3 patients testing positive for a “rare strain” of…

Assessment of the Effectiveness of Today’s Endoscope Reprocessing Practices: An Abstract Updated guidance is provided to prevent multidrug-resistant bacterial infections.

This review analyzed more than 10,000 medical device reports submitted to FDA since 2014 describing the contamination of a flexible endoscope.