Model Number VASOVIEW HEMOPRO 2 |
Device Problem
Peeled/Delaminated (1454)
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Patient Problems
Hemorrhage/Bleeding (1888); Nerve Damage (1979); Foreign Body In Patient (2687)
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Event Date 08/02/2022 |
Event Type
Injury
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Manufacturer Narrative
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Trackwise id (b)(4).
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 silicone tip of the jaws was damaged.The silicone tip came off of the device resulting in damage to the vein conduit.The surgeon deemed it unusable and this resulted in an additional incision and a new vein be harvested from the other leg.
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Manufacturer Narrative
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Trackwise#: (b)(4).
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Event Description
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¿the hospital reported that during an endoscopic vein harvesting procedure the vasoview hemopro 2 silicone tip of the jaws was damaged resulting in damage to the vein conduit.Nothing detached from the device during the evh procedure, so nothing needed to be retrieved.The vessel being harvested was noted to have a torn branch at the site where the harvesting tool stopped working.The harvesting tool had stopped working there was bleeding in the tunnel.A small cut down incision was made over the site of bleeding and was easily controlled.The vein in that area had been damaged.The surgeon deemed it unusable and made the decision to abandon the evh procedure on that extremity.This resulted in an additional incision and a new vein be harvested from the other leg.A new evh device was opened and evh was performed successfully on the opposite extremity and completed the procedure without incident.¿.
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Manufacturer Narrative
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(b)(4).Corrected sections: h6- clinical code.The device was returned to the factory for evaluation on 09/01/2022.A photograph was provided by the account.A photographic inspection was conducted.Signs of clinical use and evidence of blood and charred tissue were observed on the jaws and heater wire.The clear silicone insulation of the jaws was observed to be intact with no visual defects.An investigation was conducted on 09/08/2022.Signs of clinical use and evidence of blood and charred tissue were observed on the jaws and heater wire.A microscopic evaluation was conducted.The clear silicone insulation of both the hot and cold jaws was observed to be intact with no visual defects.The heater wire was observed to be intact with no visual defects.Based on the return condition of the device as well as the evaluation results, the reported failure "peeled; jaw" was not confirmed.The lot # 3000244418 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.
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure the vasoview hemopro 2 silicone tip of the jaws was damaged resulting in damage to the vein conduit.Nothing detached from the device during the evh procedure, so nothing needed to be retrieved.The surgeon deemed it unusable and made the decision to abandon the evh procedure on that extremity.The vein in that area had been damaged.This resulted in an additional incision and a new vein be harvested from the other leg.A replacement device was used to complete the procedure.
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Search Alerts/Recalls
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