Catalog Number C-VH-4000 |
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 05/01/2018 |
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.The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.
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Event Description
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The hospital reported that during preparation for an endoscopic vein harvesting procedure, vasoview hemopro 2 cautery tips would not close all the way.A new kit was opened and the case was completed without further issue.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 procedure for an endoscopic vein harvesting procedure, vasoview hemopro 2 cautery tips would not close all the way.A new kit was opened and the case was completed without further issue.The hospital did not report any patient effects.
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Manufacturer Narrative
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(b)(4).The hp2 device was returned to the factory for evaluation.Signs of clinical usage and evidence of blood were observed.A visual inspection was conducted.Signs if blood and small amount of char were observed on the jaws.Specks of blood was observed on the harvesting handle.A microscopic inspection determined that the heater wire was slightly flexed from the center of the hot jaw.The wire remained in place at the tip and at the base of the hot jaw.No other failures were observed.A mechanical evaluation was conducted per the instructions in instructions for use (ifu), the toggle was pushed to close the jaws to check the integrity of the jaws to align when closed.The jaws did align with each other.Jaws were able to close without difficulty.Based on the return condition of the device and the evaluation results, the reported failure mode ¿mechanical issue; jaw¿ was not confirmed but confirmed for analyzed failure "material twisted/bent; wire".Specific actions for the analyzed failure "material twisted/bent; wire" are being maintained and documented under maquet's failure investigation report (fir) system.
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Event Description
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The hospital reported that during procedure for an endoscopic vein harvesting procedure, vasoview hemopro 2 cautery tips would not close all the way.A new kit was opened and the case was completed without further issue.The hospital did not report any patient effects.
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Search Alerts/Recalls
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