(b)(4).Batch # t92913.Investigation summary: the analysis results found that the el5ml device was returned with no damage in the external components and a malformed clip inside a plastic bag.In addition, the tyvek was returned along with the instrument.In an attempt to replicate the reported event, the device was tested for functionality.Upon testing, the device was fired and the clips did not advance into the jaw.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 and 11 clips were found inside clip track.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.The reported complaint was confirmed.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 an unknown procedure, the device misfired several times.At one point, the device would fire and eject clips, but the next firing would not produce a clip at all.Sometimes the clips would eject and on other firings they would not.The device would fire and then stop firing.The clips that were ejected were not formed evenly (one leg longer than the other).The procedure was completed with no patient consequences were reported.
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