Information received by notivisa - an automated system for receipt of adverse events in (b)(6).Limited information, including details of the incident were provided.Information received indicates that the scalpel blades did not cut during use.Five material / lot number combinations were provided.All medwatch reports associated with the report from notivisa include the following: 9610612-2018-00443 (this report), 9610612-2018-00444, 9610612-2018-00445, 9610612-2018-00446, 9610612-2018-00447.
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All medwatch reports associated with this report: 9610612-2018-00443, 9610612-2018-00444, 9610612-2018-00445, 9610612-2018-00446, 9610612-2018-00447.Investigation: no product is at hand.Batch history review: the device quality and manufacturing history records have been checked for all the lot numbers (4508507992/4508827131/4508948992) and found to be according to the specification, valid at the time of production.No similar incidents have been filed with products from these batches.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 possibility that the root cause of the problem is most probably usage related.Rationale: unfortunately, due to a lack of data and without the product we can not determine the exact cause.According to the quality standard and dhr files, a material defect or production error can be excluded.There is the possibility for a usage error.No capa is necessary.
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