(b)(4) date sent: 6/28/2023 d4: batch # x9696k 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 received with no damage to the external components.In an attempt to replicate the reported incident, the device was tested for functionality.Upon testing, it was noted that the clips were not fed into the jaws in the next actuation of the trigger.In order to evaluate the condition of the internal components of the device, it was disassembled.Upon disassembling, the feed link was noted broken causing the feeding issues and 15 clips were found inside the clip track.The event reported was confirmed and it is related to improper use of the device.Possible causes for the damage found is due to the jaws may have been restricted during firing, or not fully through the trocar during firing.Please reference the instruction for use for more information.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 batch and lot number, and no non-conformances were identified.
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It was reported that during a laparoscopic distal gastrectomy, the trigger was stiff to grasp, and the clip could not be fed into the jaw when the device was used on the blood vessels.Another device was used to complete the case.There were no adverse consequences to the patient.No further information is available.
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