Concomitant medical products: cook fusion wire lock, fs-wl-o-s, erbe electrosurgical generator, unknown model.Investigation evaluation: one (1) of the two (2) reported devices were returned.Due to the condition of the returned device, we were unable to complete a full evaluation.Our laboratory evaluation of the product said to be involved confirmed the report.The wire guide lumen of the sphincterotome has been fully utilized.The outer edge of the wire guide lumen exhibits fraying and rippling along the separation line.Since the wire guide lumen was returned fully utilized, functional testing with a wire guide separating the wire guide lumen was unable to be performed.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: a corrective action has been initiated to reduce occurrences of this nature.The product said to be involved is included in the scope of the corrective actions.Prior to distribution, all fusion omni-tome pre-loaded sphincterotomes are subjected to a visual inspection and functional test to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a corrective action has been initiated in an effort to reduce occurrences of this nature.This product was manufactured prior to implementation of this corrective action.Quality assurance will continue to monitor for complaint trends.
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