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 distal tip using a digital microscope confirmed it to be smooth with no burrs.There are some edges that could fray or cut suture with enough force.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 concluded this was an isolated event.A review of risk management files found that the reported failure was documented appropriately.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.A review of the instructions for use found: ¿ it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device ¿ as with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure ¿misuse of these instruments may result in bent distal tips or jaws; and dull or uneven cutting edges the complaint was confirmed and the root cause was associated with a component failure.Factors that could have contributed to the reported event include excessive force.
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