This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation. new information added on fields: d8, h3 and h6.Since the device is more than 15 years old, the device history record was unable to be reviewed.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, a definitive root cause could not be identified.Olympus will continue to monitor field performance for this device. .
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