Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.A review of the complaint history, device history record, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that the device was opened, and there was an unknown foreign matter in the package.As the device was returned opened, cook was unable to determine where the device was manufactured out of specification.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed a total of eight nonconforming events which could contribute to this failure mode.All offending nonconformances were for loose foreign matter.These products were reworked, and all remaining devices in the lot underwent quality control activities such as a visual inspection before completion.Additional lots by the same operator were reviewed for complaints related to foreign matter.As of 26feb2019, no additional complaints for foreign matter in a sealed package have been received under these lots.It should also be noted there were no other reported complaints for this specific lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be established.However, investigation states that a possible cause could be traced to manufacturing and quality control deficiency.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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