(b)(4).Date sent: 2/13/2024.D4: batch # a9c734.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the er420 device was returned and upon inspection the jaws were found to be in a misaligned condition.In an attempt to replicate the reported incident, the device was tested for functionality; during the analysis, the instrument was cycled and it fed and formed six(6) scissored clips due to the misaligned condition of the jaws; finally the instrument locked out as intended.The event reported was confirmed and it is related to improper use of the device.Possible causes for the condition found may be if the device is closed over an existing hard object or clip placing stress on the jaws causing them to distort or yield and not return to their original dimensions/position or excessive application of torque to the jaws when positioning the device on a vessel.The reported complaint was confirmed.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.A manufacturing record evaluation was performed for the finished device batch and lot number, and no non-conformances were identified.
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