There is more information on the device evaluation.This supplemental report is being submitted to provide this information.Device history records (dhrs) for this product have been reviewed.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.There are no associated ncrs, reported scrap or recorded process deviations relating to the reported failure.As reported for this event, during reprocessing there was damage on the distal tip of the device.Physical evaluation of the device confirmed the user request.Estimation team found corrosion on the outer tube and objective window and also found leakage.Image was also blurry, which could be attributed to corroded objective window.Additionally, broken lens and spots on optical were observed.The damages observed on the device were most likely due to user mishandling.Corrosion is often incurred as a result of chemical stress and inappropriate storage environment.Section 6.0 (maintenance) and 7.0 (storage) of the device instructions for use (ifu) provide instructions regarding agents/solution and methods for appropriate cleaning, sterilization and storage of the device.Ifu alerts ¿use of any procedures not expressly recommended by gyrus acmi may adversely affect or damage gyrus acmi devices.¿.
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