The referenced device was returned to the service center.The evaluation found the confirmed "unit had an error code of e433 due to a defective generator board.The asset device was leased to the customer on (b)(6) 2020 and has had no previous repair records.The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.
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This supplemental report was submitted to provide additional information from the legal manufacturer and to update the following sections: d8, g3, g6, h2, h3, h4, h6 and h10.The legal manufacturer performed the device history records for this device 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 investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.The e433 error is activated by the device's safety system, which triggers a restart of the device.If the error cause persists, an unlimited number of periodic restarts can be triggered.In this case, error e433 was most likely caused by a defective generator board.A deeper investigation of generator boards with error e433 found a destroyed transformer tr1 to be the cause.An improved generator board was introduced into production in mid-july.As stated on the instructions for use and as a preventive measure, a suitable replacement device must be provided during an application.Olympus will continue to monitor complaints for this device.
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