(b)(4) date sent: 11/17/2023 b3: unknown, assumed first day of month that complaint was reported d4: batch # a9d446 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 without apparent damage.In addition, the tyvek was returned along with the instrument.In an attempt to replicate the reported incident, the instrument was tested for functionality.During the analysis, one(1) clip partially formed was feed due to an anti-backup failure and then it fed and formed 1 conforming clip 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 spring of the ratchet pawl was found out of position 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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