This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Probable causes for a cracked lid include: the lid contacting with a scope when it was closed and/or an external impact to the lid with a hard object.Since the device was manufactured over five years ago, it is also possible that the crack in the lid occurred due to age deterioration.The device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device that would have caused or contributed to the reported issue.The device met all specifications at the time of shipment.Design of the device or manufacturing cannot be confirmed as factors to cause the event.Per the instructions for use (ifu): "before using the equipment, always check that there is no irregularity regarding the following points on the lid and the lid packing.If there is any irregularity, cleaning fluid or disinfectant solution may leak out.¿ the lid is not cracked, broken, or otherwise damaged." the most probable cause for the reported event is user handling.
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