Trackwise (b)(4) updated sections: b4, g3, g6, h2, h3, h6, h10 the device was returned to the factory for evaluation on 02/23/2024.An investigation was conducted on 02/28/2024.A visual inspection was conducted.Both the harvesting device and cannula was returned for evaluation.There were no visual defects observed on the intact cannula.Signs of clinical use and evidence of blood was observed.There were no visual defects observed on the clear intact silicone insulation on both the cold and hot jaws.Heavy char was observed on the heater wire.The heater wire was observed to be flexed 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 condition of the heater wire.Based on the returned condition of the device as well as the evaluation results, the reported failure "material twisted/bent wire" was confirmed.The lot # 3000360578 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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