Concomitant medical products: cook fusion wire lock, fs-wl-o-s, erbe electrosurgical generator, unknown model.Investigation evaluation: the first returned device was returned with a wire guide in the port.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 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 wire guide returned with the complaint device also exhibited damage close to 27 cm from the distal end of the wire guide.The wire guide damage is likely to have been caused by the difficulty encountered during the zip exchanged.No portion of the coating appears to be missing.Due to the condition of the second 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 rippling and fraying 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 third returned device was returned with a wire guide in the port.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 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.In addition, the anchor at the distal end of the sphincterotome is pulled partially through the catheter but remains attached.The damage to the anchor of the sphincterotome is likely to have been caused by the difficulty encountered during the zip exchanged.No portion of the device appears to be missing.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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