Investigation - evaluation a review of the device history record, quality control, and specifications was conducted during the investigation.The device was not returned for evaluation.Review of device history record shows no nonconforming events which could contribute to this failure mode.Based on the information provided, and the results of the investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.Per the risk assessment no further action is required.
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