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

Model Number	G31903
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in a clear plastic bag.Provided with the return was an open pouch from the lot number provided in the report.The label matches the product returned.Our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the wire guide lumen utilized fully.The outer edge of the wire guide lumen was rippled with some fraying from 34.0cm to 88.0cm distal to the proximal zip port.Additionally, the catheter was twisted throughout the length of the device, indicating difficulty performing separation of the wire guide lumen/zip exchange.Since the wire guide lumen was returned fully utilized, functional testing of the wire guide lumen separation was unable to be performed.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: our evaluation of the returned device confirmed the report of difficulty performing zip exchange based on the condition of the returned device.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.Resistance while performing the zip exchange can occur if the catheter of the sphincterotome becomes damaged (i.E.Kink or bent).A kink or bend in the catheter can compress the wire guide lumen compromising the zipping process.A kink in the sphincterotome can occur if the device receives added pressure during advancement through the endoscope or general handling.The instructions for use caution the user "the elevator should remain open/down when advancing or retracting the sphincterotome." if the elevator of the endoscope is placed in the closed/up position with the sphincterotome inside the accessory channel, this could cause a kink in the sphincterotome.Prior to distribution, all fusion omni-tome sphincterotomes are subjected to a visual inspection and functional testing 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: based on the quality engineering risk assessment no corrective action is warranted at this time.A review of the complaint history was conducted.Based on this review, the likelihood of this type of report is rare.Quality assurance will continue to monitor for complaint trends.
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used a cook fusion omni-tome.It was reported that it was really challenging to split the catheter.They [physician and crew] were eventually able to split it with extreme effort.The procedure was successfully completed with the device in question.A section of the device did not remain inside the patient¿s body.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: UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston salem NC 27105
• Manufacturer (Section G): WILSON-COOK MEDICAL INC; 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: 24924221
• Report Number: 1037905-2026-00182
• Device Sequence Number: 9248118
• Product Code: KNS
• UDI-Device Identifier: 00827002319035
• UDI-Public: (01)00827002319035(17)281226(10)W4995641
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K172665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/20/2026

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 Model Number: G31903
• Device Catalogue Number: FS-OMNI
• Device Lot Number: W4995641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCOPE, UNKNOWN MAKE OR MODEL
• Patient Sex: Unknown