(b)(4).Date sent: 3/26/2024.D4: batch # x7033v.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 with a clip in the jaws; the clip was removed in order to inspect the jaws and they were found to be misaligned.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 eleven(11) scissored clips due to the misaligned condition of the jaws; finally the instrument locked out as intended.The damage in the device 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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