The device, was used in treatment was not returned for evaluation with all additional information provided we have not been able to establish a relationship between the device and the reported event or determine a root cause.No serial number was provided , a dhr review could not be performed.A complaint history review was performed for the product and failure mode reported, there have been further instances.The ifu has been reviewed and contains comprehensive instructions on the safe operation and use of the device.The associated risk files contain details relating to harm.However, as no harm has been alleged then additional review is not required.Probable root cause maybe a component failure.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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