(b)(4).The customer returned 24 representative samples of 005200 horizon ti micro 6/cart 180/box for investigation.The actual sample was not returned.The representative samples were returned closed in their original packaging.The returned samples were visually examined with and without magnification.Visual examination of the returned samples revealed that the clips appear typical.No defects or anomalies were observed.The clip applier was not returned.Functional inspection was performed on all 24 of the returned representative samples.A lab inventory clip applier was used.All six clips in the first cartridge that was tested were able to properly load into the jaws of the applier and were successfully applied to over-stressed surgical tubing.This was repeated for the remaining cartridges with the same result.No damage was observed to the tubing that would suggest the returned clips would cut a vessel.Damage to the vessel could be caused by various issues relating to the applier or the clips.Since neither were returned, no issue could be confirmed since no functional issues were found with the returned clips.The ifu for this product, l02428, was reviewed as a part of this complaint investigation.The ifu states, "always check the alignment of the applier jaws before use.When closed, jaw tips should be directly aligned and not offset.Alignment of the jaw is critical for safe application of the clip.If this is not done, patient injury may occur.Proper maintenance, care and cleaning are necessary to ensure proper functionality." a corrective action is not required at this time as there were no functional issues found with the representative samples that were returned.The actual sample was not returned.The reported complaint of "damage to tissue - vessel cut" could not be confirmed based on the returned samples.The customer returned 24 representative samples.Upon functional inspection, no problems were found as all clips could be loaded into the jaws of a lab inventory applier and close when applied to over-stressed surgical tubing.No damage was observed to the tubing that would suggest the returned clips would cut a vessel.Damage to the vessel could be caused by various issues relating to the applier or the clips.Since neither were returned, no issue could be confirmed since no functional issues were found with the returned clips.
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