Health product recall

Oer-Elite Automated Endoscope Reprocessor

Last updated

Summary

Product
Oer-Elite Automated Endoscope Reprocessor
Issue
Medical devices - Manufacturing defect
What to do
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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
Olympus Medical Systems Corp.
2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507
Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63777

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