MAUDE Adverse Event Report: COOK ENDOSCOPY FUSION OMNI-TOME; KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Catalog Number FS-OMNI

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 04/05/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the product said to be involved determined the cutting wire securing component located near the distal end of the sphincterotome has disconnected from the catheter.The cutting wire is intact and remains 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 is no longer connected to the sphincterotome catheter at the distal end.The securing component has a longer section measuring 3 mm and a shorter section measuring 2 mm, therefore no part of the device is missing.The cutting wire shows evidence of cautery application.A visual examination of the wire guide showed 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.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." this type of damage can occur if the distal end of the catheter is shaped manually.This sphincterotome catheter is pre-curved and is provided with a pre-curved stylet in the distal tip of the catheter.This obviates the need for manual formation.The instructions for use contain the following comment: ¿note: do not apply manual pressure to tip or cutting wire of sphincterotome in an attempt to influence orientation, as this may result in damage to device.¿ 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." the user is then instructed: "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 the sphincterotome and render it inoperable." prior to distribution, all fusion omni-tome 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: 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 Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion omni-tome sphincterotome.There was mismatching/maladjustment of the cutting wire at its distal extremity.The following additional information was received on (b)(6) 2017: "i have called customer, but unfortunately the person who was in charged of this complaint has left the hospital last friday and the new person was not aware so she is checking and will call me back.What i can tell you is that on the document they have in their system, it is written that the cutting wire is broken at the distal tip, and not misaligned so i do not know what is true or not ¿ i do not know either if it has been used or not.So i need to wait for them to call me back with more information." the following additional information was received (b)(6) 2017: "i have just talked to the customer again (pharmacist) and as i informed you yesterday, the reporter has left and there is no more information on their files about the issue and the nurse does not really remember what was the issue.Moreover, as far as the device, [it] is no longer at customer but back to cook.They cannot check to inform me so i am very sorry but i think i will not be able to bring you any reliable information on that issue." the following additional information on (b)(6) 2017: "the device has not been used at all on patient, they have realized the issue immediately when they opened the packaging, so no issue on patient.What i can tell you is that if i translate what is written in their file, the meaning is: cutting wire was detached from catheter at distal tip [cutting wire broke in one location].Nothing was lost in patient." there was no reportable information at this time.The device was evaluated on (b)(6) 2017 and it was observed that the cutting wire securing component separated from the catheter.

• Brand Name: FUSION OMNI-TOME
• Type of Device: KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 6844276
• MDR Text Key: 84939931
• Report Number: 1037905-2017-00578
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002319035
• UDI-Public: (01)00827002319035(17)200127(10)W3817681
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FS-OMNI
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/05/2017
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1