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, an external impact to the lid and/or a chemical crack due to adhered chemical solution which was not removed.The design of the device and the manufacturing process cannot be confirmed as factors to cause the event.The most probable cause for the reported event is user handling.Based on the legal manufacturer¿s investigation, the device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device that would cause or contribute to the reported issue.The device met all specifications at the time of shipment.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.
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