It was reported that, during procedure, the tip of the accu-pass direct crescent had a defect, therefore, it did not hook on/grasp the suture correctly.It is unknown what procedure was being performed.The procedure was completed with a backup device with no delay nor patient injury.
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The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection of the returned instrument shows no manufacturing abnormalities.The tip of the device is loose.A functional evaluation revealed the accu-pass was not able to function as intended.The device would not grasp the suture.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review for the reported batch number concluded this was an isolated event.The complaint was confirmed.Factors that could have contributed to the reported event include: excessive force.No containment or corrective actions are recommended at this time.
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