Results of investigation: the device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.Per photos attached the packaging for the product does slightly look damaged and possibly torn at the ends.The product was manufactured in 2015.Some potential probable causes for this event could include packaging damage in transit or storage.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.Factors and/or potential causes that could contribute to the reported event have been identified in the risk management file.No deviations were identified during device history record review.Hence, at this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
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