Pentax medical was made aware of a complaint on (b)(6) 2021 for "moisture in the lens, foggy image in the middle of the image" that occurred in the operating room, prior to use in the (b)(6) region involving pentax medical video gastroscope, model eg29-i10c, serial number (b)(4).The information provided indicated that there was no leak.The endoscope has since been inspected at the pmk service center and the customer complaint confirmed.The endoscope is currently awaiting repairs.This event meets the requirements for fda reportability.
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