Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device is not available, however an unused sample is available and has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record of the product code/lot# combination was conducted with no findings.This report is for the second device reported, for the first device reported that was used on the same patient see mdr 1118880-2020-00339.
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This report is being submitted as follow up no.1 to provide the completed investigation results.H6: investigation findings - 114 is based upon the evaluation of user facility information and the investigation of the photograph provided by the user facility; 3221 is based upon the actual device not being returned.H6 - investigation conclusion - 4310 is based upon evaluation of the user facility information and the investigation of the photograph provided by the user facility; 4315 is based the actual device not being returned.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted, however the investigation of the photographs provided by the user facility was conducted.The complaint can be confirmed for fluid issues.Based on the information given, the exact root cause of the event cannot be determined.There is no indication that any manufacturing, design or quality system issues may have led to this event.Currently, no action is recommended since this risk evaluation is within the predetermined limits in the fmea.
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