The subject device has been returned to olympus for evaluation and the reported issue was not confirmed.During evaluation, it was observed, a connector was found damaged and loose, dent was noted on the main chassis, the front panel cable was found to be corroded, scratch mark was noted on the top cover, chassis, front panel and the rear panel, the rear panel was corroded, the paint was peeled off from the top cover, minor gap was noted between the front panel and the top cover and the serial number sticker was deformed.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to e2, information was inadvertently not included on the initial medwatch.Correction to g2, adding health professional.Information was inadvertently not included on the initial medwatch.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, and since no device malfunction was confirmed during evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.
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