Product complaint #: (b)(4).Batch # r58758.Device evaluation summary: the analysis results found that the ntlc75 device was received with the firing mechanism damaged as the firing knob was detached and the slip block assembly was noted to be damaged.The device was received with one reload present.The reload was returned with the knife exposed and the proximal 38 drivers up without staples, and the remaining drivers down with staples present; the swing tab in the locked position.In addition, the doghouse of the reload was noted to be damaged.No functional test could be performed with it due to the condition of the device.The damage to the firing knob and slip block assembly is consistent with high (outside indicated use) staple forming forces; however, there is insufficient evidence to determine the cause of the higher loads.It should be noted that the cartridge reload is designed to lockout, as a safety feature, if any staples have been fired from the cartridge reload.If enough force is applied the device could be damaged.For additional information please refer to the instructions for use.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
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It was reported that in the course of a procedure (rt hemi-colectomy) using the ntlc , an error occurred in the process of firing.The blade suddenly stopped in the middle of the device, and the blade didn't move forward.As an emergency measure, the surgeon backed off the firing knob and detach it from the tissue.It is unknown what was used to complete the procedure.There were no reported adverse consequences for the patient so far.
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