Adulterated Devices
Adverse Event Reports
Device Recalls
Duodenoscopes with Disposable Components
Endoscope Reprocessing
Endoscopic Retrograde Cholangiopancreatography (ERCP)
Esophagogastroduodenoscopy (EGD)
FUJIFILM ED-580XT
MAJ-2315
Misbranded Devices
Olympus TJF-Q190V
Single-Use Endcap with Elevator
Warning letters (FDA)
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.