The subject device was received and evaluated.The complaint of burned tip was confirmed.In addition, chipped lens was observed.Device history record was reviewed and showed the product met all specifications upon release.Based on the investigation, the damage which occurred was likely due to use mishandling.However, the root cause of the reported event could not be conclusively specified.The reported failure is a known phenomenon.The device instructions for use (ifu_99-1080_bg) states: "if the white areas are not approximately equal, or are interspersed with large dark areas, the light carriers may be damaged.Check the distal tip for burns." (inspection, page 10); "keep the distal tip of any electrode, probe, laser fiber, or other ancillary device in the field of view at all times when active." (warnings, page 4) olympus will continue to monitor complaints for this device.
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