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

Model Number G31903

Device Problems Material Separation (1562); Use of Device Problem (1670)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 03/14/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: erbe electrosurgical generator; cook acrobat 2 calibrated tip wire guide, awg2-35-260.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 has disconnected from the catheter.The condition of the device prohibited a functional test of the device 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 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 sphincterotomes 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 sphincterotome tip was manually formed, 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) with endoscopic sphincterotomy (est), the physician used a cook fusion omni-tome sphincterotome.The physician inserted the sphincterotome into the endoscope with a cook acrobat 2 calibrated tip wire guide, and tried to access the ampulla.The physician found that the cutting wire was broken.A new fusion omni-tome sphincterotome was used.There was no reportable information at this time.Per the cook sales representative on 21-mar-2019: it looked like the cutting wire broke in one (1) location with no detachment, but it was not clear.There was no reportable information at this time.The device was returned on 10-apr-2019 and the evaluation of the device determined that the cutting wire securing component had separated and a portion is missing.The initial reported 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
• 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: 8577964
• MDR Text Key: 152917552
• Report Number: 1037905-2019-00219
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 00827002319035
• UDI-Public: (01)00827002319035(17)210917(10)W4120532
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K052051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2021
• Device Model Number: G31903
• Device Catalogue Number: FS-OMNI
• Device Lot Number: W4120532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 05/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2018
• 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