(b)(4).Manufacturing site evaluation: this instrument is not available for investigation.According to the available information, there were no negative consequences for the patient.The device quality and manufacturing history records have been checked for the lot number and found to be according to the specification, valid at the time of production.No similar incidents have been filed with products from this batch.No product available and therefore it is hardly possible to determine an exact conclusion and root cause.It is assumed that the cause of the failure is not product related.There is the possibility that the root cause of the problem is most probably usage related.A capa is not necessary.
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