H10: h3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A visual evaluation of the device showed the suture capture is broken in three pieces and returned in a separate bag.There are no other visible deficiencies.A functional evaluation showed that the trigger and lock will open/close the jaw and deploy the suture passer.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states one undated photo of the device was provided for review and confirms the reported breakage.The complaint was confirmed and the root cause was associated with unintended use of the device.Factors that could have contributed to the reported event include: (excessive force; tissue thickness; damage or debris on the device tip between passes.No containment or corrective actions are recommended at this time.
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