Investigation: no product is at hand.Batch history review: a review of the device quality and manufacturing history records was not possible because the lot number is unknown.Conclusion and root cause: based on the information available as well as a result of our investigation, the root cause of the failure is most probably related to an insufficient usage.Rationale: due to the lack of information, we cannot determine a final root cause of this issue.Based on the quality standards, we exclude a material or manufacturer related error.It is conceivable, an insufficient usage, like bending the fibre optics during handling or reprocessing, caused a breakage of the fibre optics.No capa is necessary.
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