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

Model Number G31911

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2020

Event Type  malfunction  

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook fusion omni-tome pre-loaded sphincterotome.It was initially reported that the sphincterotome "snapped when bowing." there was no reportable information at this time.Our evaluation of the returned device on (b)(6) 2021 determined that the cutting wire securing component had separated from the tip.According to the initial reporter, a section of the device did not remain inside the patient¿s body, but a section of the cutting wire securing component had broken and detached from the device, and was not included in the return of the device.No further information was provided by the initial reporter, and it was stated that the patient did not require any additional procedures and the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Pma/510(k) # k172288.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.However, the cutting wire is intact and remains securely attached to the sphincterotome at the proximal end.A section of the cutting wire securing component has broken and detached from the device.The broken section is estimated to be 3.0mm in length and 0.5mm in diameter.The broken section was not included in the return.The cutting wire exhibits slight evidence of a cautery application (blackening of the cutting wire was noted).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 omni-tome pre-loaded sphincterotomes are subjected to a visual inspection to ensure device integrity.The visual inspection ensures the product is free of kinks.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.

• Brand Name: FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME
• 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 (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 13314174
• MDR Text Key: 284978039
• Report Number: 1037905-2022-00026
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002319110
• UDI-Public: (01)00827002319110(17)230203(10)W4315388
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/21/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2023
• Device Model Number: G31911
• Device Catalogue Number: FS-OMNI-35
• Device Lot Number: W4315388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2021
• Initial Date FDA Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OLYMPUS ENDOSCOPE, MODEL UNKNOWN