(b)(4).One (1) cartridge of catalog number 544230 hemolok ml clips (b)(4) was received used, opened without original packaging; lot # was not confirmed with samples received.During visual inspection it was observed that cartridge was received with (b)(4) clips placed in slots: clips looked in good condition.Functional inspection: clips ((b)(4)) were removed from the slots to review the condition of the clips (posts & hinge); clips undamaged.Then clips were loaded manually into cartridge to perform the functional inspection.(b)(4) hem-o-lok clips were loaded into the clip applier p/n 544171, batch # 04e0800117-020; then loaded properly/correctly into the clip applier, no quality issues were found.A closure test was then performed on the (b)(4) clips, which closed properly/correctly.After the closure test the (b)(4) clips were reviewed/verified (pulled) to duplicate the failure mode.Samples received did not confirm the defect reported by the customer clips not closing/ clip b during visual inspection.In addition, a functional inspection was performed with clips received, and the device worked properly.A corrective action is not required at this time.
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