According to the reporter, during a laparoscopic rectopexy, when the surgeon was tacking the mesh into the pubis bone, the tacks were able to be fired normally from the device, but were not able to penetrate and hold correctly onto the tissue, the component of the device disengaged into the cavity of the patient and were retrieved.They opened 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 noted the timing was disrupted and disengaged from the device.Functionally, the handle could be actuated.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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