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 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 condition of the device prohibited a functional test because 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. A section of the cutting wire securing component has broken and detached from the device. The broken section is estimated to be 3 mm in length and 0. 5 mm in diameter. The broken section was not included in the return. The cutting wire does not show evidence of cautery application. 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. " 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. ¿ 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 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

In preparation for a procedure, the user selected a cook fusion omni-tome sphincterotome. The cutting wire of the sphincterotome was broken during pre-test. There was no reportable information at this time. The device was evaluated on (b)(6) 2018 and the investigation determined that the cutting wire securing component had separated, and 3 mm detached and was not included in the return. This occurred prior to patient contact; there was no impact to the patient.

• 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 (Section G): 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: 7855788
• MDR Text Key: 119663202
• Report Number: 1037905-2018-00396
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• PMA/PMN Number: K052051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/24/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/09/2020
• Device Catalogue Number: FS-OMNI
• Device Lot Number: W3835703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial