Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation.A review of the documentation including the complaint history, device history record (dhr) and quality control, as well as a visual inspection of photos of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, photos of the device were provided from the complainant.The complaint was able to be confirmed based on customer testimony and the provided photos, which showed a small, unidentified particle within the sealed packaging of the device.There is evidence that this device was manufactured out of specification.Additionally, a document-based investigation evaluation was performed.It was concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) for the complaint device lot (9416175) revealed no non-conformances.A database search found that this complaint is the only one associated with the complaint lot number.Therefore, there is no evidence of additional nonconforming material or complaints from this lot in house or in the field.Based on the information provided, no product returned, and the results of our investigation, a definitive root cause was traced to a quality control deficiency during manufacturing.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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