H10: h3, h6: the reported device was received for evaluation.A visual evaluation showed one device was not returned in any original packaging.The suture capture has dislodged from the upper jaw.No other visible defects.A functional evaluation showed pulling the lever will close the jaw and deploy the suture passer needle.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 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 an application of unintended inappropriate or excessive force to the device, attempted correction of a damaged device, or an impact event inconsistent with normal use.No containment or corrective actions are recommended at this time.
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