Block h6: imdrf device code a020503 captured the reportable event of seal compromised.Block h10: the device was returned without the packaging.Analysis did not identify any defects with the returned device.During the functional inspection, the device had full articulation in both directions and the lithovue was tested for image on a lithovue touch pc.The device displayed a live, clear image.The reported complaint is not confirmed.Based on the most relevant information, the device met all manufacturing specifications and a risk review confirmed that the event is accounted for in the risk documentation.The reported complaint was not confirmed as the packaging was not returned.Based on all gathered information and the results of the product analysis, the complaint investigation conclusion code selected is cause not established, indicating, the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.
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