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

Catalog Number	FS-OMNI-35
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: erbe electrosurgical generator.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed 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 measures 5 mm, therefore no part of the device is missing.The cutting wire does not show 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.In addition, 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.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 precurved and is provided with a precurved 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.¿ 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 can contribute to separation of the catheter and cutting wire securing component.The instructions for use caution the user: "elevator should remain open/down when advancing or retracting sphincterotome." this activity will aid in device preservation.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 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 or Problem Description
During a sphincterotomy, the physician used a cook fusion omni-tome pre-loaded sphincterotome.The cutting wire broke.[the device was] not in a torqued position, or in any unusual longer positions, and the user did not rotate the device.The delayed [distal] cutting wire pulled away from the catheter [cutting wire securing component separation].The user immediately removed the device from the patient.[the user] opened another fusion omni-tome pre-loaded sphincterotome to complete the procedure.[there was] no harm to the patient.

• Brand Name: FUSION OMNI-TOME PRE-LOADED 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: 7544097
• Report Number: 1037905-2018-00221
• Device Sequence Number: 177324
• Product Code: KNS
• UDI-Device Identifier: 00827002319110
• UDI-Public: (01)00827002319110(17)210316(10)W4035571
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K052051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/25/2018

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 Catalogue Number: FS-OMNI-35
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/30/2018
• Device Age: 1 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PENTAX DUODENOSCOPE, UNKNOWN MODEL