Category: Misbranded Devices

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.

Considerations Not Addressed in the FDA’s Communication Discussing Olympus’ New Instructions for Reprocessing the TJF-Q180V Duodenoscope

March 27, 2015 — On March 26, 2015, the FDA issued a safety communication: Olympus Validates New Reprocessing Instructions for Model TJF-Q180V Duodenoscopes — click here. This Olympus safety communication…

The STERIS System 1E Liquid Chemical Sterilant Processing System: Looking Back and Forward

July 1, 2015 — Almost four years ago, on April 5, 2010, the Food and Drug Administration (FDA) cleared the STERIS System 1E Liquid Chemical Sterilant Processing System, or “SS1E,”…