(b)(4).Batch # r9469h.Device analysis: the analysis results found that the el5ml device was returned with no damage in the external components.In addition, the tyvek was returned along with the instrument.In an attempt to replicate the reported incident, the instrument was tested for functionality.During the analysis, the device was cycled and it fed and formed 8 conforming clips.The device was noted to have the tip of the advancer bent.The instrument was disassembled, upon disassembly the advancer was confirmed to be bent.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.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 lot r4101h number, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device batch r9469h number, and no non-conformances were identified.
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