The device is not accessible for testing as it remained implanted in the patient.The review of historical data indicated that no other similar complaint was reported for the same sterilization lot number.The device history records review concluded that there is no non-conformance / planned deviation in relation with the event reported.One retention sample from same sterilization lot as the involved device was visually inspected by the quality assurance supervisor.No stain/halo was found on the internal and external lids, which could be in relation with the event.The retention sample is in compliance with the specifications from a product/packaging point of view.The pictures sent by the customer were inspected by qa supervisor.Main elements of his assessment are as follows: the oily stains observed on the pictures sent by the customer on the inner lid look like glycerol stains that do not affect the quality of the product, since glycerol is an integral part of the product.This phenomenon of oozing could be accelerated depending on the final and intermediate storage conditions.This defect is known and acceptable.The conducted investigation indicates that the involved product complies with specifications.The observed glycerol stains do not constitute an unusual phenomenon and do not affect the product quality and performance.Device remains implanted.
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When opening the box, the physician noticed that there were stains on the cover of tray.The outer box was clean, so the physician did not realize the contamination before opening the box.Normally, the physician refuses to use devices with this kind of contamination.However, it was an emergent operation in midnight, and there was no substitute graft in the hospital, so the physician still inserted it in the patient.Patient status is stable currently.
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