(b)(4).Date sent: 7/24/23.D4: batch # x9683y.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 returned with no apparent damage and the tyvek was returned along with the instrument.In addition, the one clip partially formed, six unformed clips and three conforming clips inside a petri dish.In an attempt to replicate the reported incident, the instrument was tested for functionality.During the analysis, one clip partially formed was feed due to an anti-backup failure and then it fed and formed 2 conforming clips as expected; in addition, the lockout mechanism was found to be non-functional.In order to evaluate the device¿s internal components the instrument was disassembled.Upon disassembling of the device, the ratchet pawl was found damaged causing the anti-backup and lockout failures.Although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following caution: prior to loading a clip in the jaws and firing the instrument: ensure that the jaws are fully open by verifying that the line of demarcation between the jaws and the instrument shaft is past the distal end of the trocar cannula.Prior to positioning the jaws around the tubular structure or vessel, load a clip into the jaws by partially squeezing the trigger in a smooth continuous motion for approximately one-third of the total firing stroke.Position the jaws with the preloaded clip completely around the tubular structure or vessel to be ligated.The structure to be ligated should be positioned against the apex of the clip.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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