The returned device used in treatment, was returned for evaluation.There was no relationship found between the returned device and the reported incident.A review of the device history records for the reported lot number 2023580 showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review for lot number 2023580 for the past 3 years found no related failures.Visual inspection shows a device which was returned deployed.The instrument was returned with an opened bracket.There were no manufacturing abnormalities found on the device.Functional evaluation revealed that the two step trigger performed as intended.The bracket could be opened /closed as specified.The needle could be extended without any issues.The complaint was not verified as the device performed as intended during the test.The root cause could not be determined with certainty as the device performed as intended.Factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: (1) improper handling of the two step trigger (2) the bracket get caught on tissue (3) the bracket got sticky during the surgery there were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.No containment or corrective actions are recommended at this time.
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