(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated and the reported cable break appears to be related to user technique of over-turning the knob, as the knob was turned almost a full turn during preparation.The reported mechanical issue of loss of tip deflection and noise were the result of the cable break.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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