Health Canada — Medical Devices · Canada · 2024-10-03 · Type II
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Reported risk: During product testing, Olympus identified an intermittent loss of function of the ofp-2 flushing pump caused by an internal component connection failure. in the event that the connection failure occurs, the ofp-2 device will return to or remain in the "off" condition and the operator will not be able to use the flushing function. Through its investigation, Olympus determined that this issue resulted from an alternate tool being used during the manufacturing of one (1) lot of the subject component. Olympus has received three (3) complaints that are potentially applicable to this issue. No adverse events have been reported. Recall start date: September 20, 2024
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