(b)(4).Batch #: u94p9p.Investigation summary: the analysis results found that the el5ml device was returned with no apparent damage.In an attempt to replicate the reported event, the device was tested for functionality.Upon testing, the device was fired, and the clips did not advance into the jaw.The device was noted to have the tip of the advancer bent.The instrument was disassembled and upon disassembly, the advancer was confirmed to be bent and two clips were found inside clip track.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.Please note that prior to loading a clip in the jaws, ensure that the demarcation between the jaws and the device shaft is past the end of the trocar cannula.Additionally, excessively applying a side load to the jaws, causing them to partially collapse, could result in a clip malformation.The device jaws should be fully open and parallel upon initiating the firing of the device.Please reference the instruction for use for more information.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 lot/batch number, and no non-conformances were identified.
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