(b)(4).Batch # r92c4l.Device analysis: the analysis results found that the el5ml device was returned with no damage in the external components and inserted through a b5lt trocar.In addition, the tyvek was returned along with the instrument.Upon cycling, the instrument was noted to be empty and locked out.The instrument was disassembled, upon disassembly the advancer was found 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.The lot history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the packaging process.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
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