This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 9 years since the subject device was manufactured.Based on the results of the investigation, it is likely error code e101 occurred due to an increase in temperature due to the accumulation of dust in the device.However, a definitive root cause could not be determined.It is likely the lamp malfunction occurred due to excessive application of thermal grease.However, a definitive root cause could not be determined.The following information is stated in the instructions for use (ifu): ¿6.3 insertion of the lamp.¿ do not apply the heat compound to the glass surface and the ceramic part of the examination lamp.If any compound gets on the glass surface, wipe it off with a clean, lint-free cloth.Otherwise, the examination lamp may be damaged, and it may cause malfunction of the light source.¿ apply enough heat compound.If not enough heat compound is applied, the heat can cause lamp ignition failures.¿ olympus will continue to monitor field performance for this device.
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