Catalog Number C-VH-3000 |
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 01/27/2017 |
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 an endoscopic vein harvesting procedure, vasoview hemopro jaws popped out at the tip.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.Signs of blood and clinical use were observed.The heater wire was flexed away from the hot jaw but remained attached at the base and the tip of the jaw.Slight amount of charred tissue was observed on the hot jaw.No other visual defects were observed.Based on the return condition of the device and the evaluation results, the reported complaint is confirmed for the reported failure mode "bent wire".
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro jaws popped out at the tip.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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