The device was manufactured in april 2008.The final manufacturing date is not available as the dhr did not include the packaging or labeling operations.The suspect device was sent to olympus for evaluation.The returned device was received with its connector detached.Burn marks were observed on the cable where the cord was damaged and severed.Microscope examination of the burned portion showed that the insulation had been slightly melted, and the wire had been charred.No kinks or cuts were found on the cable.The function test could not be performed because the cable was damaged.A review of the device history record found no deviations that could have caused or contributed to the reported event.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, the reported failure was most likely due to the device being used beyond its service life and/or the instruction for use (ifu) not being followed.However, a definitive root cause of the reported issue could not be identified.The device's instruction manual provides the following cautions, which may help to prevent the issue: "when used as intended, this product is subject to wear or damage depending on the intensity of use.Inspect the product prior to each use to ensure it has no externally visible defects, including wear, kinks, cuts or pinching.Using this product when damaged may be hazardous." "this product has a restricted service life.Do not use the cable for a period of more than one year.Using the cable beyond one year may be hazardous." olympus will continue to monitor field performance for this device.
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