Public recall detail

Evis Exera III Video System - Gastrointestinal Videoscope

2024-11-01

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Recall Safety notice
Quick summary

Quick summary: Evis Exera III Video System - Gastrointestinal Videoscope. Date: 2024-11-01.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Evis Exera III Video System - Gastrointestinal Videoscope. Date: 2024-11-01.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandOLYMPUS MEDICAL SYSTEMS CORP.
ProductEvis Exera III Video System - Gastrointestinal Videoscope
IssueMedical devices - Labelling and packaging
Recall classType II
IdentificationRA-76429

Affected products

ProductEvis Exera III Video System - Gastrointestinal Videoscope
LotMore than 10 numbers, contact manufacturer.
ModelGIF-1TH190
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionEvis Exera III Video System - Gastrointestinal Videoscope

Issue

Olympus previously issued revised cleaning instructions for the GIF-1TH190 on October 11, 2023, to issue new updated channel drying steps. Olympus conducted user evaluation, through human factors validation, and determined further clarification is required to improve the instructions for easier understanding of each drying step. As a result, Olympus is issuing a revised IFU addendum that informs customers that the channel drying time has been extended by 12 minutes to purge water from the channels. This is accomplished by drying each channel for 3 minutes, in the sequence described in the addendum. Ensure all reprocessing personnel are completely knowledgeable and thoroughly trained on the new water purge requirements. Olympus has received 16 reportable complaints related to this issue. Recall Start Date: October 18, 2024

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General and plastic surgery
CompaniesOlympus Medical Systems Corp. 2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-76429
Background{}
CompaniesOlympus Medical Systems Corp. 2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507
AudiencesHealthcare
Source updated2024-11-01

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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