Catalog Number C-VH-4000 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/22/2019 |
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 were no ncmr¿s for the reported lot number.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 2 heating element/wire dislodged.Hospital was able to complete case with same device.The hospital did not report any patient effects.
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Manufacturer Narrative
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(b)(4).A lot history record review was completed for lots 25144071, 25144181, and 25144316; the last 3 lots shipped to the account prior to the event date.There were no ncmr's recorded in the lot history.
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 heating element/wire dislodged.Hospital was able to complete case with same device.The hospital did not report any patient effects.
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Search Alerts/Recalls
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