Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation ¿ evaluation.A review of the documentation including the complaint history, device history record, quality control, and photos of the complaint device was conducted during the investigation.The visual inspection of the complaint device could not be completed, as the complaint device was not returned; however photos of the complaint device were received and used in the investigation.The photos confirmed the presence of a particle of foreign matter within the sealed packaging of the device.Additionally, a document-based investigation evaluation was performed.It was concluded that sufficient controls are in place to detect this failure mode prior to release.A review of the device history record for lot 9211173 showed no nonconformances that could have contributed to this failure mode.It should be noted that there were no other complaints reported for this lot number.There is no evidence to suggest there is any nonconforming product in house or out in the field.Based on the information provided, no returned product and the results of the investigation, a definitive cause can be traced to manufacturing and a quality control deficiency.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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