Internal complaint reference (b)(4).Article; li da, liu yuxin, yu hailing, & dong jinye.(2017).Observation of haemorrhage after low-temperature plasmaectomy of tonsils and adenoids in children.Qilu medical journal, (4), 444-446.
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H10: h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.Insufficient product identification information was provided and thus a manufacturing record, complaint history, risk management and corrective and preventive actions, non conformance, probabilistic risk assessment/health hazard evaluation review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.Without supporting clinical/medical documents, a thorough investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should any additional clinical information be provided this complaint will be re-evaluated.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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