This supplemental report was submitted to provide additional information from the original equipment manufacturer (oem) for mdr.The oem performed a device history record review and no abnormalities were found.An investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.Based on similar complaints, the oem determined possible cause of the reported broken lid can be attributed to the lid was contacted with a scope when it was closed, something hard hit the lid.Though it was presume the event was due to the user handling, it is difficult to specify.As stated on the ifu (instruction for use) and as a preventive measure, the user manual states: chapter 3 inspection before use, 3.2 inspecting the lid and lid packing.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.Olympus will continue to monitor complaints for this device.
|