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(b)(4).Batch #: u95j6e.Additional information was requested and the following was obtained: rep reported when they were resecting the small bowel even though it was hemostatic the tissue layers were not fused together.Could still see edges.It was multiple mesentery vessels.It was after they removed the colon layers of the mesentery were oozing so he used sutures and ties to correct.Unknown anticoagulation pre op for patient but they had received blood a few days prior to the procedure.Unknown if patient had any disorder or level of blood loss.It was blood loss from colon mesentery.First time using for surgeon.There were no alert screens.Patient status is unknown.Investigation summary: the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the nslx120l device was received with no apparent damage.The device was tested on the generator and passed all functional testing.The energy output delivered from the device was verified.All tones were heard during functional testing.The device was tested with the test media and no anomalies were found.There were no anomalies noted with the functionality of the device.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reach on the cause of the reported event.The event described could not be confirmed as the device performed without any difficulties noted.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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