Since the subject device has not been returned to olympus medical systems corp.(omsc) for the evaluation, the exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
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Olympus medical systems corp.(omsc) was informed from the user that the image of the subject device was not displayed and the display color was pink at the preparation for use.At the incoming inspection for the repair, olympus india checked the subject device.(b)(4) found that the subject device could not be started up and all leds on the front panel were blinking continuously due to the printed circuit board failure of the subject device, and the fans of the power supply unit were not worked due to the power supply unit failure of the subject device.There was no report of patient injury associated with this event.
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This supplemental report is being submitted to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Olympus india found the following on the subject device.The device did not working.The device did not start up and all led indicators on the front panel continued to light up due to failure of the cp board.The fan of the power unit did not work.Omsc reviewed the manufacture history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, based upon available information, there was the possibility that the reported phenomenon was attributed to the following causes; as more than 12 years have passed since manufacture of this product, it is presumed that the parts on the circuit board and the fan of the power unit deteriorated over time due to long-term repeated use, and they failed.While all led indicators lighted up during startup, they continued to light up because the startup did not complete due to failure of the cp board.
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