Catalog Number C-VH-3000 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/28/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro would not stop heating when activation was no longer used.He pulled the hemopro out of the device and it was red hot.He disconnected the cord and the heat stopped.He finished the case with a new hemopro device.The hospital did not report any patient effects.
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Manufacturer Narrative
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(b)(4).
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro would not stop heating when activation was no longer used.He pulled the hemopro out of the device and it was red hot.He disconnected the cord and the heat stopped.He finished the case with a new hemopro device.The hospital did not report any patient effects.
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro would not stop heating when activation was no longer used.He pulled the hemopro out of the device and it was red hot.He disconnected the cord and the heat stopped.He finished the case with a new hemopro device.The hospital did not report any patient effects.
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Manufacturer Narrative
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(b)(4).
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Search Alerts/Recalls
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