Catalog Number C-VH-4000 |
Device Problems
Material Separation (1562); 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 10/12/2016 |
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 2 wire/heating element on the jaws was dislodged and separated.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 clinical usage was observed.A visual inspection determined that the heater wire was flexed away from the hot jaw and was bent.The wire remained attached at the base of the jaw.Based on the returned condition of the device the reported complaint was confirmed for "bent wire; heater detached." specific actions for the confirmed failure mode are being maintained and documented under maquet¿s corrective and preventative (capa) system.
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 wire/heating element on the jaws was dislodged and separated.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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