MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC UTS PRECURVED ULTRA TAPER SPHINCTEROTOME; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	G22490
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.Our evaluation of the product said to be involved confirmed the report.The cutting wire has broken and a portion detached.The detached segment, measuring approximately 1.4cm, was not included in the return.Due to the breaks in the cutting wire, the sphincterotome will not respond to handle manipulation and is no longer operational.The cutting wire's remaining segments do not exhibit evidence of a cautery application (no blackening of the cutting wire was noted).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: our evaluation of the returned device confirmed the cutting wire is broken and a portion detached.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.A broken cutting wire can occur if the tip of the device is over flexed.The instructions for use caution the user: "do not over flex or bow the tip beyond 90 degrees, as this may damage or cause the cutting wire to break." cutting wire breakage can occur if the elevator of the endoscope remains in the closed/up position when retraction of the sphincterotome is attempted and additional pressure is applied; this could have contributed to cutting wire breakage.The instructions for use caution the user with the following comment: ¿the elevator should remain open/down when advancing or retracting the sphincterotome.¿ the instructions for use also instructs the user with the comment: ¿advance the tip of sphincterotome into the endoscope accessory channel and continue to advance in short increments until the device is endoscopically visible.¿ prior to distribution, all uts precurved ultra taper 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: based on the quality engineering risk assessment no corrective action is warranted at this time.A review of the complaint history was conducted.Quality assurance will continue to monitor for complaint trends.Additional comments regarding this report: based on the information provided that 1.4 cm of the cutting wire is missing and was not returned with the device, a cook representative has been directed to contact the medical facility involved to inform the customer of this investigation finding.
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp) in common bile duct, the physician used a cook uts precurved ultra taper sphincterotome.It was initially reported that the sphincterotome was advanced down the scope and the assistant bowed per the doctor¿s instructions.A sphincterotomy was started.The dr stopped using cautery to see if they liked the size of the cut.The dr decided to extend the cut and stepped on the pedal again and that¿s when the cutting wire broke.The dr decided to not continue with the sphincterotomy so they removed the device from the scope, keeping the metii-21-480 wire in place and then used an olympus balloon extractor.The issue with the cutting wire did not cause any issues and the procedure was completed successfully.There was no reportable information at that time.The device was received on 15apr2026 and determined to have a piece missing during investigation [cutting wire breaks and section is missing - subject of report].A section of the device did not remain in 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: UTS PRECURVED ULTRA TAPER SPHINCTEROTOME
• 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: 25127001
• Report Number: 1037905-2026-00219
• Device Sequence Number: 18823693
• Product Code: KNS
• UDI-Device Identifier: 00827002224902
• UDI-Public: (01)00827002224902(17)280918(10)W4971824
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/08/2026

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: G22490
• Device Catalogue Number: UTS-25M
• Device Lot Number: W4971824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2025
• 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: DUODENOSCOPE - UNKNOWN MODEL; METII-21-480; OLYMPUS BALLOON EXTRACTOR
• Patient Sex: Unknown