(b)(4).The lot # 3000357260history 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.The device was not returned to maquet cardiac surgery for investigation; however, a photograph was provided by the account.A photographic evaluation was conducted.Signs of clinical use and evidence of charred material was observed on the heater wire.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.There were no other visual defects observed.Based on the non-return of the device and the photographic evaluation, the reported failure "material twisted/ bent wire" was confirmed.
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