Concomitant medical products: erbe electrosurgical generator, unknown model.Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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.A review of the complaint history was conducted.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
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During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion omni-tome pre-loaded sphincterotome.When placing the wire guide through the sphincterotome, there was no issue.When removing the sphincterotome, although the wire guide is "blocked" [locked], while peeling [exchanging], the wire guide came out [lost wire guide access to the duct].The following occurred: "deterioration of the sphincterotome, while peeling, making it no longer usable thereafter, and also withdrawal of the wire guide (that followed the sphincterotome), causing the procedure to last longer (program disorganization, longer anesthesia, risk of failing to reinsert the wire guide)." another sphincterotome was used to complete the procedure.
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