The hospital reported that during an endoscopic saphenous vein harvesting procedure after the dissection process was complete, vasoview hemopro 2 was about to be used to ligate the vein branches.When attempting to ligate the first branch, the harvester noticed that the metal within the jaws had separated from the outer coating of the jaws.The jaws were not open at all when the harvesting tool was inserted into the cannula.Due to this defect, it was decided that the device was not safe to use and it was immediately removed from the surgical field.The device was never used to ligate a branch.A new hemopro 2 kit was opened and the case was finished with no other issues.No injuries occurred due to the defect.The only surgical delay was the time needed to open a new hemopro 2 kit which was about 2 to 3 minutes.
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Trackwise#: (b)(4).Updated sections: b4, g3, g6, h2, h3, h6, h10.The device was returned to the factory for evaluation on 02/19/2024.An investigation was conducted on 02/22/2024.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.There were no visual defects observed on the intact clear silicone insulation on both the cold and hot jaws.The heater wire was observed to be flexed and bent away from the hot jaw from the base of the hot jaw with detachment at the tip of the hot jaw.No other visual defects were observed.No electrical testing was conducted due to the conditon of the heater wire.Based on the returned conditon of the device as well as the evaluation results, the reported failure "material twisted/bent wire" was confirmed.The lot # 3000347797 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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