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

Model Number	G55815
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) # k172288.Investigation evaluation: our laboratory evaluation of the product said to be involved determined via visual inspection of the catheter that the distal tip of the device appears to be distorted/damaged.It is not known at what point the distal tip became distorted/damaged.No section of the sphincterotome device appeared to be missing.During the laboratory evaluation the handle and drive wire functioned as intended and completely bowed the distal tip of the catheter.A brown liquid was observed inside of the catheter near the distal end and a clear liquid was observed throughout the device.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.Devices released for distribution go through multiple inspections to detect such defects.Inspections include confirmation of adequate tip bowing, a visual inspection to confirm proper forming of the dome shape tip, and proper insertion of the shaping wire at the distal end.Therefore, it is unknown how or at what point the tip of the catheter became damaged/distorted.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: the cause of the deformation of the distal tip of the device is unknown.However, it is possible that the tip was deformed due to contact with an external force.The proposed source of the external force to the catheter is unknown.Evidence of a manufacturing nonconformity was not observed.The instructions for use also advise the user to: ¿visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use." 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: 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.
Event or Problem Description
In preparation for a procedure, the user selected a cook fusion omni-tome pre-loaded sphincterotome.It was initially reported that upon inspection, the tip of the sphincterotome was cracked.They simply opened another device and continued with the procedure.There was no reportable information at this time.Our evaluation of the returned device on 3/8/2022 determined that the distal tip of the catheter is cracked, it is also jagged and a piece of the catheter is protruding out [subject of report].This occurred prior to patient contact; there was no impact 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
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 14014224
• Report Number: 1037905-2022-00157
• Device Sequence Number: 17722675
• Product Code: KNS
• UDI-Device Identifier: 00827002558151
• UDI-Public: (01)00827002558151(17)241119(10)W4539113
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/05/2022

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: 11/19/2024
• Device Model Number: G55815
• Device Catalogue Number: FS-OMNI-35-480
• Device Lot Number: W4539113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown