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: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 3(5) x probability 2(5) of occurrence) according to din en iso 14971 is still acceptable.Explanation and rationale: there is the possibility that the tip of the titanium clip cassette became pre-damaged during the assembly process.According to the applicable instruction for use, the user shall make sure that the tip is not damaged during that process.However, due to a lack of data and without the product we cannot determine an exact conclusion and root cause for the reported issue.According to the quality standard, a production error and a material defect can most probably be excluded.If further investigations are required, the product should be provided for examination.Conclusion and measures / preventive measures: 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 investigation 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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