Investigation - evaluation: a review of the complaint history, drawings, manufacturing instructions, trends, and quality control was conducted during the investigation.The complaint device was not returned, therefore no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted this is the second complaint associated with this lot number.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.
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