Oer-Elite Automated Endoscope Reprocessor

The OER-elite is intended for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories. Olympus discovered the detergent and alcohol tank tubing may have been incorrectly assembled in the OER-elite. Olympus has received one (1) non-injury complaint of the misassembled tubing, which was discovered during onsite installation of a new OER-elite prior to use for endoscope reprocessing. The endoscopes reprocessed by the OER-elite with the incorrectly assembled detergent line and the alcohol line could have a risk to patient of infection by insufficient disinfection and a risk to patient of toxicity from residual detergent on the endoscope.

Recall start date: 2021-12-13