H3, h6: the device used in treatment was returned for evaluation.Establishing a relationship between the reported event and device.A visual inspection was performed and showed there was no blockage observed.The piston assembly was in the middle position within the chamfer.Functional inspection was performed and showed there was no flow upon insertion into the water source.The device was manually primed.The device cut and functioned as designed.Probable root cause may be an obstructed fluid supply.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.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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