(b)(4).Investigation - no product at hand.Batch history review - a review of the device quality manufacturing documents was not possible because the lot number was unknown.Conclusion and root cause - based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient usage.Rationale - with the lack of information and without any product available for analysis, a definitive root cause cannot be determined.Based on the quality standards we exclude a material or manufacturer caused error.According to the ifu, we recommend to make skin incisions in order to avoid excessive application of force thus a risk for the patient.
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It was reported that the patient's skin was harmed intraoperatively.During endoscopic surgery on (b)(6) 2018, the outer threads of the trocar sleeves damaged the skin.After several days, the skin was noted as "recovered well".Further details were not provided.This report addresses the second reusable trocar sleeve.Associated medwatches: 9610612-2018-00595, 9610612-2018-00596 (this report).
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