The device, used in treatment, was returned for evaluation.The visual inspection reported no defects.The functional evaluation confirmed the device did not work, establishing a relationship with the event reported.The root cause was identified as a software corruption issue.A review of manufacturing records for the reported lot/batch, found no non-conformances or anomalies during production.The device/product met all specifications upon release into distribution.Complaint history for the reported event has been reviewed, revealing further instances in the past three years.No further actions are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.
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