Catalog Number ARD568330902 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet (b)(4), (b)(4).The issue will be investigated by the manufacturing site.
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Event Description
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On (b)(6) 2017 maquet sas became aware of incident with one of surgical lights- volista.As it was stated, light handles came unscrewed and loose from devon adapters and one of them lasted in surgeon's hand.There was no patient involvement, however we decided to report the issue in abundance of caution.(b)(4).
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Manufacturer Narrative
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(b)(4).Exemption # e2018005.(b)(4).The issue is still being investigated by the manufacturing site.
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Event Description
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Ref- (b)(4).
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Manufacturer Narrative
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The issue is still being investigated by manufacturing site.
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Event Description
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Ref - (b)(4).
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Search Alerts/Recalls
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