(b)(4).Batch #: t93h1h.The er320 device was returned for analysis and upon inspection, the jaws were found to be in a yielded condition.In an attempt to replicate the reported incident, the device was functionally evaluated.Upon firing of the device, the remaining 11 clips were ejected due to the condition of the jaws.Finally, the instrument locked out as intended.Possible causes for the condition of the yielded jaws may be if the device is closed over an existing hard object or clip, placing stress on the jaws and 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.It is known from the history of the device that the condition of the jaws may lead to dropping/ejected clips.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
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