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

Model Number	G31903
Medical Device Problem Codes	Material Separation (1562); Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Non-healthcare professional.Investigation evaluation: our laboratory evaluation of the product said to be involved determined that the cutting wire securing component located near the distal end of the sphincterotome was disconnected from the catheter.The condition of the device prohibited a functional test of the used device because the cutting wire securing component located near the distal end of the sphincterotome was disconnected from the catheter.The cutting wire was 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 was no longer connected to the sphincterotome catheter.A section of the cutting wire securing component was broken and detached from the device.The broken section was 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 shows 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: responses to additional questions indicated that the distal end of the device was formed manually.The instructions for use advise the user: "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." this is the most likely cause for the reported observation.Prior to distribution, all fusion omni-tome sphincterotome are subjected to a visual inspection and functional test to ensure device integrity.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 user manually formed the sphincterotome tip, 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 or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a cook fusion omni-tome sphincterotome.The cutting wire broke during procedure.There was no reportable information at this time.The device was evaluated on 15-apr-2019 and it was determined that the cutting wire securing component had separated from the sphincterotome catheter and a portion was missing.The initial reporter stated that a section of the device did not remain inside the patient¿s body; however, the location of the missing portion is unknown.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: FUSION OMNI-TOME
• 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: 8601129
• Report Number: 1037905-2019-00252
• Device Sequence Number: 2192865
• Product Code: KNS
• UDI-Device Identifier: 00827002319035
• UDI-Public: (01)00827002319035(17)200717(10)W3891657
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K052051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2019

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 Expiration Date: 07/17/2020
• Device Model Number: G31903
• Device Catalogue Number: FS-OMNI
• Device Lot Number: W3891657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR