According to the reporter, during laparoscopic inguinal hernia repair, while tacking the mesh in place, the surgeon fired the device but it could not fire.They could not give a full squeezed to the handle.They used another device to complete the case.There was no patient injury.
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Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the instrument noted the handle was partially retracted.The device loading unit (dlu) was received preloaded with a tack in the e piece.No damage was noted to the e piece.Functionally, the device was able to rotate properly.The tack was removed from the e piece.During firing, the tacks seated properly, but handle did not retract after firing.The leaf spring was loose on handle. the unit was disassembled and it was noted the leaf spring was detached and rolled. a review of the device history record indicates this product was released meeting all medtronic quality release specifications at the time of manufacture. however, an assembly error was identified during product analysis. the root cause of the reported condition is due to an excessive amount of adhesive being applied to the spring retainer during the assembly process. a process improvement has been initiated to prevent this condition from recurring.If information is provided in the future, a supplemental report will be issued.
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