Investigation evaluation: our evaluation of the returned device confirmed the report of incorrect cutting wire orientation.During the laboratory analysis, the sphincterotome was advanced through a duodenoscope that is placed in a simulated biliary position.The duodenoscope has an accessory channel that is 4.2 mm in diameter.The catheter exited the endoscope with the cutting wire facing 10 o'clock.The distal end was advanced into the simulated papilla and bowed and the cutting wire oriented in the 9 o'clock position.The sphincterotome catheter was subjected to a close visual examination and twisting was observed at the distal end in addition to a kink in the catheter 141.5cm from the distal end.A discrepancy or anomaly that could have contributed to the reported event was not found during our laboratory analysis of the returned product.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 definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.Responses to additional questions indicated that the distal end of the device was formed manually after improper orientation was observed.The instructions for use advise the user: "do not apply manual pressure to tip or cutting wire of sphincterotome to influence orientation, as this may result in damage to device." prior to distribution, all tri-tome pc triple lumen 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 review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.Based on the information provided that the distal end of the device was formed manually after improper orientation was observed, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.
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During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook tri-tome pc triple lumen sphincterotome.The sphincterotome was pushed through the working canal of the endoscope and came out distortedly from the working canal [incorrect cutting wire orientation].A section of the device did not remain inside the patient's body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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