(b)(4).Batch # v95a6v.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Upon visual analysis of the returned sample it was determined the el5ml device was returned with no apparent damage in the external components.Upon visual inspection, one unformed clip was noted to be partially fired in the jaws.The clip was manually removed.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 five conforming clips.In addition, the device locked out as intended.The event described could not be confirmed as during testing, the device performed without any difficulties noted.Although the returned clip was found to be malformed, no conclusion could be reached regarding the cause of the staple malformation.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following: "caution: insert the clip applier through an appropriately-sized trocar.The empty jaws will passively collapse as they are inserted through a 5 mm trocar and reopen when completely through the trocar.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.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 our quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
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