Model Number EG29-I10C |
Device Problems
Failure to Align (2522); Optical Distortion (3000)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/07/2021 |
Event Type
malfunction
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Event Description
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Foggy image detected after repair at qc inspection.This event occurred at the time of during inspection.There was no report of patient harm.
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Manufacturer Narrative
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Model eg29-i10c-us is available in the usa with a 510k number k190805.Evaluation summary: the cause is that the air containing moisture that has entered the objective lens / led condenses due to temperature changes and causes fogging.
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Manufacturer Narrative
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Evaluation summary: we checked the returned unit and confirmed, that the knob loosen.Based on the result, we concluded that it was caused, due to the angle wire worn out.
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Search Alerts/Recalls
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