Aspen surgical received a report from the distributor indicating that a flexible light handle cover was discovered with a potential seal issue.Samples were not available for evaluation.A review of the device history record was performed for the lot numbers.No non-conformance's were noted relating to the reported issue.Pouch material of the product is a breathable packaging material and would allow air to escape from inside the pouch.Due to no samples provided, no further information is available on the product at this time.No further actions required.Device not available.
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