H3, h6: the device intended for use in treatment was returned for evaluation.A relationship between the reported event and device could not be established.A visual inspection was performed and showed no damage to the device.Functional inspection was performed and showed the complaint of pressure/power setting issue could not be reproduced.Unit passed functional testing.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.A complaint review indicated other failures reported.Probable root cause is determined to be an obstruction.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for adverse trends related to this product.
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