The product was not returned for investigation and the reported failure mode was not confirmed.Alleged failure: fogging and condensation: probable root cause: laser welding seal failure, distal/proximal window solder failure, damage to optical train, damage to needle, damage to distal or proximal windows, moisture intrusion, end of life wear-out, environmental disturbance: endoscope colder than dew point.Environmental disturbance: fluid entrapment between the coupler and eyepiece.Junction (eyepiece only).Use error.The device manufacture date is not known.The failure mode will be monitored for future reoccurrence.H3 other text: 81.
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