(b)(4).Additional information: the analysis results of the er320 device found that it was received with a clip in the jaws; the clip was removed in order to inspect the jaws and they were found to be in good condition.In an attempt to replicate the reported incident, the device was tested for functionality.During the analysis, the device was cycled and it fed and formed seven scissored clips, and then ten conforming clips were fed and formed; in addition, the device locked out as intended.Although it is not possible to conclude how the circumstances occurred, it is known from the history of the instrument that an incorrect/excessive application of torque to the jaws during instrument use creates a misalignment of the tips.In addition as per the instructions for use ¿do not excessively twist or torque the instrument jaws when positioning the instrument on a vessel and firing.Excessive twisting or torquing may result in clip malformation¿.The batch record was reviewed and no anomalies were noted during the manufacturing process.
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