This supplemental report is being submitted to provide review of the device history records (dhr), unique device identifier (udi) number and investigation conclusion.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The reported failure was most likely due to user mishandling.As stated on the ifu (instruction for use) the user manual states: this product is a precision device; handle it with care.Avoid rough or violent handling, which may cause equipment damage, take special care to ensure all cables are undamaged.Olympus will continue to monitor complaints for this device.
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