This supplemental report is being submitted to provide the subject device evaluation result.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation but was returned to olympus china.Omsc reviewed the device history record (dhr) of the subject device and confirmed no irregularity.Based on the evaluation of olympus china, the cause of the reported event was attributed to the failure of the main circuit board.The cause of the main circuit board failure could not be identified because there was no delivery of the actual product.Based on the reported phenomenon, it is inferred that the phenomenon occurred when an abnormality was detected in the internal circuit.The cause of the internal circuit malfunction is presumed to be the failure of the pressure sensor mounted on the main board.The cause of the failure of the pressure sensor mounted on the main board is presumed to be due to any of the following process errors.Oxygen entered the device and the electrode of the pressure sensor was oxidized and corroded.The wiring inside the pressure sensor was peeled off due to the oxidation corrosion.Because foreign matter (epoxy) had adhered to the mounting of the component due to a mistake, the wires inside the pressure-sensor had peeled off due to adherence of the foreign matter (epoxy).
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