Trackwise id#: (b)(4) updated sections: b-4, g-4, g-7, h-2, h-3, h-6, h-10 the device was returned to the factory for evaluation on (b)(6) 2023.An investigation was conducted on (b)(6) 2023.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed on the device.Evidence of charred material was observed between the jaws.A microscopic inspection 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 flexed way from the base of the hot jaw, bent, and separated from the tip of the jaw.Based on the returned condition of the device and evaluation results, the reported failure "material twisted/bent; wire" was confirmed.The lot # 3000349241 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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