Device was evaluated.Inspection of the device confirmed the reported issue.The device outer tube was observed to be bent at the proximal end.In addition, the objective cover glass was fractured with dents in the edge.Internal lenses were noted to be broken.Device history records were reviewed and showed the product met all specifications upon release.Based on device inspection results, physical damage found on the device was most likely due to user mishandling.To prevent inadvertent damage to the device, the device ifu (instruction for use) states: study this manual and other labeling thoroughly for safe handling and storage.Misuse of instruments can cause injury to the patient and could have an adverse effect on the procedure being performed.Do not drop instruments or allow them to be struck by other objects.Olympus will continue to monitor complaints for this device.
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