(b)(4).Only event year known: 2018.Device analysis: the analysis results confirmed that the lx105 device was returned non functional as the jaws were misaligned; therefore, the clips could not be loaded into the jaws.No conclusion could be reached as to what may have caused the found condition of the jaws.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The batch history records were reviewed and certed by external manufacturing that the manufacturing criteria was met prior to the release of the equipment. .
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