This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Corrected fields: g2 (health professional and company representative should be unmarked), h6- component code, h6- problem code.Additional information added to field h3, h6, h7 and h9.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 6 years since the subject device was manufactured.The device was returned to olympus for inspection, and based on the results of the investigation, the customer's allegation could not be confirmed.As the reportable malfunction could not be reproduced, the presumed cause and a definitive root cause could not be determined.However, the device inspection results suggested that the cr board needed to be replaced.Olympus will continue to monitor field performance for this device.
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