Model Number VH-4000 |
Device Problem
Failure to Deliver Energy (1211)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/31/2023 |
Event Type
malfunction
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 would not cut and seal branches.It would not transect tissue due to not receiving electrical energy.The hp2 cord was changed, which did not work.A new device was opened and worked properly.No procedural delay.No injury to the patient.
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Manufacturer Narrative
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Tw id (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
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Manufacturer Narrative
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Trackwise id# (b)(4).The lot # 3000307742 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.H3 other text : device discarded.
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Event Description
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N/a.
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Search Alerts/Recalls
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