(b)(4).Date sent: 3/28/2024 d4: batch # a9e07f 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.In addition, two(2) malformed clips and one(1) conforming clips were returned inside a plastic bag.In an attempt to replicate the reported incident, the instrument was tested for functionality.During the analysis, the device was cycled and it fed and formed eight(8) conforming clips.The device was noted to have the tip of the advancer bent.The instrument was disassembled, upon disassembly the advancer was confirmed to be bent.The event reported was confirmed and it is related to improper use of the device.Please note that prior to loading a clip in the jaws, ensure that the demarcation between the jaws and the device shaft is past the end of the trocar cannula.Additionally, excessively applying a side load to the jaws, causing them to partially collapse could result in a clip malformation.The device jaws should be fully open and parallel upon initiating the firing of the device.Please reference the instruction for use for more information.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.
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