MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION TRIPLE LUMEN SPHINCTEROTOME; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	G31533
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: erbe electrosurgical generator, cook acrobat 2 calibrated tip wire guide, awg2-35-205.Occupation: non-healthcare professional.Investigation evaluation: our evaluation of the product said to be involved determined that the cutting wire securing component located near the distal end of the sphincterotome had disconnected from the catheter.The cutting wire was intact and remained securely attached to the sphincterotome at the proximal end.However, due to the catheter and securing component disconnection, the distal end of the cutting wire was no longer connected to the sphincterotome catheter at the distal end.The securing component was intact, therefore no part of the device was missing.The cutting wire showed evidence of cautery application.A visual examination of the catheter showed no kinks or 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.Separation of the cutting wire securing component and the catheter can occur if the tip of the sphincterotome 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." other factors that can contribute to separation of the cutting wire securing component and the catheter include manipulating the handle with the catheter in a coiled position or with the precurved stylet inside the cannulating tip.The instructions for use advise the user: "upon removing device from package, uncoil and straighten sphincterotome.Carefully remove precurved stylet 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 sphincterotome and render it inoperable." prior to distribution, all fusion triple lumen sphincterotomes 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 and this represents an unusual occurrence.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.
Event or Problem Description
During a sphincterotomy, the physician used a cook fusion triple lumen sphincterotome.When they went to perform a sphincterotomy, the [cutting] wire at the tip of the sphincterotome shattered and broke off.They were unable to make a cut and they had to come out, exchange the equipment and start again.There was no reportable information at this time.Additional information was received on 13-feb-2019: this was a sphincterotome complaint.The [cutting] wire did not fall off and is still attached to the sphincterotome.The equipment was exchanged [with] a new wire guide and sphincterotome.It then was reloaded into the endoscope, and the procedure was subsequently completed.There was no reportable information at this time.The device was received on 25-feb-2019 and the evaluation determined that the cutting wire securing component had separated from the catheter.Our attempts to collect additional information regarding patient outcome were unsuccessful.While the complainant did not specify if the patient experienced any adverse effects or required additional medical procedures due to this event, the information able to be collected does not reasonably suggest the patient was adversely impacted.

• Brand Name: FUSION TRIPLE LUMEN SPHINCTEROTOME
• Common Device Name: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 8439924
• Report Number: 1037905-2019-00106
• Device Sequence Number: 16560008
• Product Code: KNS
• UDI-Device Identifier: 00827002315334
• UDI-Public: (01)00827002315334(17)210921(10)W4122721
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K033203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/21/2021
• Device Model Number: G31533
• Device Catalogue Number: FS-25M-35
• Device Lot Number: W4122721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1