During an endoscopic procedure, the physician used a cook tri-tome pc triple lumen sphincterotome.It was initially reported that the physician had detected that the cutting wire orientation was deviated before use.This is not considered reportable.Our evaluation of the returned device on (b)(6) 2022 determined that the cutting wire was broken and a portion is missing.Our attempts to collect additional information regarding patient outcome have been unsuccessful.While the complainant did not specify if the patient experienced any adverse effects or required additional medical procedures due to this event, a portion of the cutting wire measuring approximately 7.0mm is missing and was not included in the return of the device.The information able to be collected does not reasonably suggest the patient was adversely impacted.
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Pma/510(k) # k172665.Investigation evaluation: our laboratory evaluation of the returned device said to be involved confirmed the report.A visual examination of the distal end of the returned device showed that the cutting wire had broken.A portion of the cutting wire measuring approximately 7.0mm was missing and not included in the return of the device.The cutting wire remaining within the catheter shows evidence of cautery application and liquid was observed in the catheter.The catheter shows no kinks/bends.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.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.A broken cutting wire can occur if the tip of the device is over flexed.The instructions for use caution the user: "do not over flex or bow tip beyond 90 degrees, as this may damage or cause cutting wire to break." cutting wire breakage can occur if the handle is manipulated with the catheter in a coiled position or with the precurved stylet inside the cannulating tip.The instructions for use advise the user to: ¿upon removing device from package, uncoil and straighten sphincterotome." the user is then instructed to: ¿carefully remove precurved stylet wire from cannulating tip." the instructions for use contain the following comment: "note: do not exercise handle while device is coiled or precurved stylet is in place, as this may cause damage to the sphincterotome and render it inoperable." cutting wire breakage can also occur if the cutting wire makes contact with the endoscope when electrosurgical current is applied to perform the sphincterotomy.The instructions for use caution the user: "when applying current, ensure cutting wire is completely out of endoscope." the instructions caution the user: ¿contact of cutting wire with endoscope may cause grounding, which can result in patient injury, operator injury, a broken cutting wire and/or damage to endoscope." if the elevator of the endoscope remains in the closed/up position when retraction of the sphincterotome is attempted and additional pressure is applied, this could contribute to cutting wire breakage.The instructions for use caution the user: "elevator should remain open/down when advancing or retracting sphincterotome." this activity will aid in device preservation.Prior to distribution, all tri-tome pc triple lumen sphincterotome are subjected to a visual inspection and functional test to ensure device integrity.The functional test includes bowing the sphincterotome to ensure the distal end responds to handle manipulation.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.
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