Product was not returned for evaluation.However, this issue was previously confirmed through events reported in 2183787-2017-00005 and 2183787-2017-00006.The malfunction was discovered prior to device use, and there was no impact to the patient.After pouches are sealed a 100% visually inspection is performed to verify the seal.The requirement for inspection of packaging prior to use is detailed in the ifu and is a standard surgical preparation practice.The root cause was attributed to inadequate process execution - and inadequate work environment.Recall is estimated to be issued to fda by 02/10/2017.Corrective actions are detailed in a capa and include adding performance based training, clarifying procedures, and adding a single piece flow at the pouch sealing and pouch seal verification work stations.
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