As of today no patient declaration of consent is available.Thus the analysis is based on the inspection of the quality documents associated with the manufacture of this particular device.The quality documents accompanying the manufacturing process for this device were re-investigated.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.Based on the inspection of the quality documents no conclusion can be drawn regarding the rot cause of the clinical observation.Should the patients declaration of consent become available, this report will be updated.
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