(b)(4) ae1.Ae 1 - respiratory, thoracic, mediastinal: pneumonia; device related, procedure not related, pre-existing no; tumour reduction therapy witihin 30 days prior procedure - chemo.The stent remained in place (or inside the patient) at 6 months post placement or at the time of death.
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This file was created from pmcf study to capture pneumonia.Device evaluation: the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.With the information provided, a document-based investigation was conducted.Manufacturing records: prior to distribution, all evo-fc-r-20-25-12-e devices are subjected to functional checks and visual inspection to ensure device integrity.It may be noted that there has been discrepancies in rpn number provided.Review historical data: n/a.Instructions for use and/label: it should be noted that the instructions for use (ifu0067) which informs the user about the potential complications "those associated with upper gi endoscopy include, but are not limited to: allergic reaction to contrast or medication, aspiration, cardiac arrhythmia or arrest, fever, hemorrhage, hypotension, infection, perforation, reflux, respiratory depression or arrest, vomiting.As per medical advisor ¿ifu: aspiration; infection." there is no evidence to suggest the user did not follow the ifu or label.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient condition related, as per instructions for use, aspiration and infection are listed as a potential complication.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Corrective action/correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation: according to the customer, respiratory, thoracic, mediastinal - pneumonia.Confirmed quantity of 01 device, confirmed used.According to the initial reporter, the stent remained in place (or inside the patient) at 6 months post placement or at the time of death.As per medial advisors input "medical intervention s=4".Investigation findings conclude that a possible root cause could be attributed to patient condition related, as per instructions for use, aspiration and infection are listed as a potential complication.Complaint is confirmed based on customer and/or rep testimony.
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