Aesculap inc.(importer, registration no.2916714) is submitting this report on behalf of aesculap ag (manufacturer, registration no.9610612).Exemption number: e2014018 no product at hand, therefore an investigation was not possible.Batch history review: the product does not require batch management; a review of the device quality and manufacturing history records is not possible.Conclusion and root cause: no product available and therefore it is hardly possible to determine an exact conclusion and root cause.We assume that the cause of the failure is not product related.There is the possiblity that the root cause of the problem is most probably usage related.Rationale: according to the quality standard a material defect and production error can be excluded.Without the product we cannot determine the exact cause.There is the possibility for a usage error due to improper handling or mechanical overload situation by torsion or high leverage with the instrument.If further investigations are required, the product should be provided for examination.No capa necessary.
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