Evis Exera III Video System - Gastrointestinal Videoscope

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