Model Number VH-4000 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/16/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Tw id (b)(4).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.H3 other text : device not returned.
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 jaws separated.The heater wire became disconnected from the jaw.The jaws were completely closed during insertion.A new device was used to complete the procedure.There was a procedural delay.There was no patient effect.
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Manufacturer Narrative
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Trackwise #: (b)(4).The lot # 3000350117 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.
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Search Alerts/Recalls
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