Visual analysis was performed on the returned device.The reported connection issue was unable to be confirmed due to the condition of the returned unit.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history revealed no indication of a lot specific product quality issue.The investigation was unable to determine a cause for the reported connection issue.It may be possible that damage to the optical fiber occurred during use causing the reported connection issue and error message; however, this could not be confirmed.The observed separation of the window tube was not reported and likely occurred during post-use handling/packing for return.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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