Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of both product noted the timing was disengaged.Additionally, the trigger was jammed.Functionally, the trigger of both instruments was actuated after disassembling the body from the tube.Tacks were jammed in the tubes of the instruments and did not deploy due to the timing disruption.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the reported condition is caused by an instrument that has been exposed to excessive force while applying helixes to a surface.If a helix is fired over improper surfaces it can provoke the exertion of excessive force to the handle causing the unit to disrupt the timing and to a possible jam.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.If information is provided in the future, a supplemental report will be issued.
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According to the reporter, during the firing of device in the inguinal space in a laparoscopic inguinal hernia procedure, the first few tacks were successful on 2 device before it jammed.The metal tacks fell into patient cavity and was able to retrieved using graspers.There was no patient injury.
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