Investigation ¿ evaluation.A review of the complaint device photos, complaint history, device history record, and quality control were conducted during the investigation.The device was not returned, but the customer provided photos of the complaint device.A particle of foreign matter is visible within the sealed packaging of the devices.Additionally, a document based investigation evaluation was performed.The device master record showed sufficient controls are in place to address this failure mode, including inspecting all package seals, examining each seal for defects and foreign matter, and ensuring each seal is solid and smooth.A review of the device history record showed no nonconformances.There are no related nonconformances or other complaints from this lot so there is no evidence that nonconforming product exists in house or in the field.Based on the information provided, no returned product, and the results of the investigation, the root cause was traced to manufacturing, specifically 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.
|