Internal complaint reference (b)(4).H10 h3, h6: the reported device was received for evaluation.A visual evaluation showed the device was not returned in any original packaging.The suture capture is missing from the upper jaw and was not returned.There are no other visible defects.A functional evaluation showed pulling the lever will close and deploy the suture passer needle, these failures have been determined to be related to the reported event.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.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.The root cause has been associated with unintended use of the device.Factors that could have contributed to the reported event include: excessive force, tissue thickness or damage or debris on the device tip between passes.No containment or corrective actions are recommended at this time.
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