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Oer-elite automated endoscope reprocessor

Official notice

31 Dec 2021

Last checked

31 Dec 2021

Medium riskHealth Canada
Watch Olympus Medical

An official Health Canada notice concerns 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 Published 2021-12-31.

What to do now

Contact the manufacturer if you require additional information.

Recall number

63777

Official notice

2021-12-31

The hazard

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

How to check if you're affected

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

63777

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Affected products

Product 1

Affected Products - Oer-Elite Automated Endoscope Reprocessor, Lot or serial number - All lots., Model or catalog number - OER-ELITE

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Olympus Medical, Oer-elite Automated Endoscope Reprocessor

Manufacturer

Not provided

Phone

Not provided

Brand: Olympus Medical, Oer-elite Automated Endoscope Reprocessor.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

63777

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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