Investigation - evaluation: a review of complaint history, manufacturing instructions, and quality control data was conducted during the investigation.The complaint device was not returned therefore, device failure analysis and physical examination of the device used in this case could not be performed.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.The lot number of the device is not known; accordingly a review of the device history record could not be conducted.Based on the limited information provided and results of the investigation a definitive root cause could not conclusively be determined.Per the quality engineering risk assessment no further action is required.Monitoring for similar complaints will continue.
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