The device, was used in treatment was returned for evaluation.Photos were provided for evaluation and could establish a relationship between the reported event and device, however a root cause could not be determined.A visual inspection was performed and showed no damage to the device.Functional inspection was performed and showed no problem found.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture.A complaint history review found other related failures.Probable root cause maybe an obstruction.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.
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