Correction: investigation - evaluation: a review of the complaint history, device history record, quality control, as well as a review of photos of the device provided by the customer was conducted during the investigation.The customer was unable to return the complaint device for investigation.However, an examination of complaint device photos confirmed the presence of foreign matter in the outer pouch of the sealed device package.As a result, the device was found to be out of specification per quality control documents for foreign matter in outer pouch.Additionally, a document based investigation evaluation was performed.Based on the review of current documentation, sufficient controls and inspections are in place to prevent the release of nonconforming product related to the reported failure mode.A review of the device history record showed no relevant nonconformances that could have contributed to the reported failure mode.It should be noted that there have been no other complaints reported for lot 9026746 or similar device lots.Based on the information provided, examination of product photos and the results of our investigation, a definitive root 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.
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