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Catalog Number FS-OMNI
Device Problems Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/02/2018
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: erbe electrosurgical generator. 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 portion measuring 3 mm and a shorter portion measuring 2 mm, hence no portion of the cutting wire is missing. The cutting wire shows evidence of cautery application. A visual examination of the catheter showed fraying approximately 36. 5 cm from the distal end. A kink was observed in the catheter approximately 27 cm from the distal end. The entire breakthrough channel has been utilized and the catheter showed areas of rippling. 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 nonconformity that could be related to the observation reported by the user was found. The device goes through several inspections in manufacturing, final quality check (fq), and packaging departments prior to leaving the facility in an effort to ensure proper workability. The inspection processes would have removed any products having this nonconformance prior to distribution. Therefore, 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. The additional information provided indicated that the distal end of the catheter was formed manually. This may have contributed to the reported observation. Cutting wire securing component separation 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 to influence orientation, as this may result in damage to device. ¿ 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: a review of the complaint history was conducted. 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. Additional comments regarding this report: based on the information provided that the distal end of the catheter was formed manually, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.
Event Description
During an endoscopic retrograde cholangiopancreatography (ercp) and endoscopic sphincterotomy (est), the physician used a cook fusion omni-tome sphincterotome (fs-omni). For ercp cannulation and est, the nurse unwrapped the fs-omni and checked whether there was a problem or not. There was no problem. The doctor successed [successfully performed] cannulation and est, [then] removed the fs-omni. He dilated the duct and ampulla. For additional est, he inserted the fs-omni in the scope and accessed the ampulla. But the cutting wire of the fs-omni was a broken. He removed the fs-omni and used new fs-omni. The device was evaluated on 02/16/18 and it was observed that the cutting wire securing component separated from the catheter. The following additional information was received on 02/18/18: the physician and nurses found that the cutting wire anchor [cutting wire securing component] was broken, when they watched the endoscopic view. Then, the physician removed the sphincterotome. The additional detached portion was not found and retrieved [based on the device evaluation, no portion of the anchor is missing].
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Manufacturer (Section D)
4900 bethania station rd
winston-salem NC 27105
Manufacturer Contact
scottie fariole
4900 bethania station rd
winston-salem, NC 27105
MDR Report Key7334778
MDR Text Key102449079
Report Number1037905-2018-00094
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeKR
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 03/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberFS-OMNI
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/02/2018
Device Age5 MO
Event Location Hospital
Date Manufacturer Received02/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/07/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial