(b)(4).Date sent: 9/22/2022.Batch # x94u9z.Investigation summary the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the el5ml device was was received with no damage in the external components.In an attempt to replicate the reported incident, the device was tested for functionality.Upon testing, the device was cycled and in the next cycles, the clips were not fed into the jaws.In order to evaluate the condition of the internal components the device was disassembled; upon disassembling the feeder shoe tab was found to be damaged causing the feeding issues.In addition, 14 clips were found inside the clip track.No conclusion could be reached regarding what may have caused the reported incident.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot and batch number, and no non-conformances were identified.
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It was reported that during a laparoscopic hepatectomy, a clip could not be fed into the jaw from 1st firing, although the trigger was grasped.The surgeon checked the device by grasping the trigger and then the indicator showed the orange bar.The device was used on the blood vessels.Another device was used to complete the case.There were no adverse consequences to the patient.
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