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 05/09/2018 |
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 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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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 cutter within jaw lifted off the insulation.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Manufacturer Narrative
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(b)(4).The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed.Blood and charred tissue was observed on the heater wire.The heater wire was observed to be flexed away from the hot jaw at the center, but remained attached at both the base and tip of the hot jaw.No other visual defects were observed.Based on the return condition of the device, the reported complaint "bent wire" was confirmed.Specific actions for the reported failure mode 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 an endoscopic vein harvesting procedure, vasoview hemopro 2 cutter within jaw lifted off the insulation.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Search Alerts/Recalls
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