(b)(4).Batch # u94k8m.Investigation summary: the analysis results found that the el5ml device was received with one jaw disengaged from the cam.This condition would not allow the jaws to collapse in order to form the clips.No functional test was performed due the condition of the device.In order to evaluate the condition of the internal components of the device, it was disassembled.Upon disassembling, no anomalies were found.In addition, eight clips were found inside clip track.No conclusion could be reached as on what caused the jaw disengaged.Although there is no direct evidence of use error, the instructions for use do contain the following caution: possible causes for the condition of the jaw disengaged from the cam may be inadvertent force, twisting or pressure being placed on the device jaws, using the jaws of the device as a dissector/ retractor or damage to the jaws while entering the trocar.It should be noted that as part of our quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.
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