Oer-Elite Automated Endoscope Reprocessor
Brand(s)
Summary
Contact the manufacturer if you require additional information. |
Affected products
Affected Products |
Lot or serial number |
Model or catalog number |
---|---|---|
Oer-Elite Automated Endoscope Reprocessor |
All lots. |
OER-ELITE |
Issue
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 |
Additional information
Details
Olympus Medical Systems Corp. |
2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507 |
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