(b)(4) date sent: 2/28/2017.Batch # n91e99.The analysis results found that a b12lth device was returned outside its original package.In addition, the tyvek was returned for analysis.The device was measure to confirmed that a sleeve assembly is a 11 mm and obturator is a 12 mm.No conclusion could be reached as to what may have caused the reported incident.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
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It was reported that prior to a sleeve gastrectomy procedure, the device was received with a trocar 12mm diameter and a cannula of 11mm in its initial packaging.Thus, surgeon couldn't use the product.Another like device was used to complete the procedure.There were no adverse consequences for the patient.
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