Trackwise#: (b)(4).The device was returned to the factory for evaluation on 02/13/2024.An investigation was conducted on 02/19/2024.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed.There were no visual defects observed on the clear intact silicone insualtion on both the cold and hot jaws.Charred material was observed on the heater wire.There were no visual defects observed on the intact heater wire.Based on the returned condition of the device as well as the evaluation results, the reported failure "material twisted/bent wire" was not confirmed.The lot # 3000359277 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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