This event occurred at the time of before use.There was no report of patient harm.There is a blurry / foggy image.There is moisture under the led cover glasses.This device is classified as import for export, therefore 510k is not applicable.Model eg29-i10c is available in the (b)(4) with a 510k number k131902.Evaluation summary it was caused due to a condensation of moisture in the ccd unit by changing the temperature outside of the endoscope.This report is being filed as part of the pentax backlog management plan.
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