MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC COTTON CANNULATOME II PC PROTECTOR; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	G49196
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continued section e: phone: (b)(6).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 cutting wire securing component located near the distal end of the sphincterotome has disconnected from the catheter.Due to the catheter and securing component disconnection, the distal end of the cutting wire is no longer connected to the sphincterotome catheter at the distal end.The securing component has a longer section measuring 3 mm and a shorter section measuring 2 mm therefore no part of the device is missing.The cutting wire has bent and torn through the catheter at the proximal end of the cutting wire and at the distal green band where the anchor exited the catheter.There was not evidence of a cautery application on the cutting wire (no blackening of the cutting wire was observed).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 visual evaluation of the returned device confirmed the cutting wire securing component (anchor) has separated from catheter (w/o detachment).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.Separation of the cutting wire securing component and the catheter can occur if the tip of the sphincterotome is over flexed.The instructions for use caution the user with the following comment: ¿do not over flex or bow the tip beyond 90 degrees, as this may damage or cause the cutting wire to break.¿ prior to distribution, all cotton cannulatome ii pc protector 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: based on the quality engineering risk assessment no corrective action is warranted at this time.A review of the complaint history was conducted.There have been a total of 2 reported occurrences of this nature during the time period reviewed.Therefore, this report represents an unusual occurrence.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 procedure in the duodenum and bile duct, the physician used a cook cotton cannulatome ii pc protector sphincterotomes.It was reported that the tip of the cutting wire came undone.[cutting wire securing component separates from cathete-subject of report].The papilla was located in a diverticulum and was actually probed blindly.After unsuccessful visualization, the papillotome was removed and it turned out that the cutting wire had come loose.The examination was terminated and will then be performed via ptcd [percutaneous transhepatic biliary drainage].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: COTTON CANNULATOME II PC PROTECTOR
• 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: 23619659
• Report Number: 1037905-2025-00802
• Device Sequence Number: 10090936
• Product Code: KNS
• UDI-Device Identifier: 00827002491960
• UDI-Public: (01)00827002491960(17)280401(10)W4926716
• Combination Product (Y/N): N
• Initial Reporter Country: DE
• PMA/510(K) Number: K172665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/21/2025

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: G49196
• Device Catalogue Number: CT-25M-P
• Device Lot Number: W4926716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• 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: ENDOSCOPE - UNKNOWN MAKE OR MODEL.
• Patient Sex: Unknown