Model Number EG-3870UTK |
Device Problem
Unintended Movement (3026)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/21/2021 |
Event Type
malfunction
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Event Description
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The time of event is unknown.There was no report of patient harm.Video image failure.
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Manufacturer Narrative
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We checked the returned unit and confirmed the ccd module as defective.Based on the result, we concluded that it was caused due to the excessive force applied on the ccd module.In addition, we confirmed that the segment loosened and the bending rubber perforated; however, they are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report and/or the risk analysis results, it was evaluated to submit mdr.
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Event Description
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The time of event is unknown.There was no report of patient harm.Video image failure.
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Manufacturer Narrative
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We checked the returned unit and confirmed the ccd module as defective.Based on the result, we concluded that it was caused due to the excessive force applied on the ccd module.In addition, we confirmed that the segment loosened and the bending rubber perforated; however, they are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report and/or the risk analysis results, it was evaluated to submit mdr.
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Search Alerts/Recalls
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