Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Manufacturing specifications were valid at the time of production.Explanation and rationale/conclusion and root cause: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing - , or design- related failure.In the event that the complaint product will be provided for investigtaion in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.
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